FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Eileen Zhou Michael Channing A B M Mahfuz ul Alam Research Associate Group Chief - Positron Emission General Manager, Quality Operations Neuralstem Tomography Department ACI HealthCare Limited Germantown, MD, United States NIH Dhaka, Non-US, Bangladesh [email protected] Bethesda, MD, United States [email protected] [email protected] Abe Wong ABHIJEET GUJAR Adam Ebbinghouse CCO Chief Operating Officer QC Associate Gmpsigma SETHU KP Pharmaceutical Technology, Inc. Seattle, WA, United States Porvorim Goa, Non-US, India Bloomington, IN, United States [email protected] [email protected] [email protected]
Adil Gatrad Adiseshu Modugula Aditiben Patel Director, Quality Systems RA Regulatory Specialist Actavis MSN USAMMDA Parsippany, NJ, United States Hyderabad, Non-US, India Frederick, MD, United States [email protected] [email protected] [email protected]
Adriana de la Cruz ahsanul haque Aimee Gogarty Manager CSO Quality Coordinator Laboratorios Pisa SA de CV FDA Mallinckrodt Jalisco, Non-US, Mexico silver spring, MD, United States Port Allen, LA, United States [email protected] [email protected] [email protected]
Aislyn Fronzak Ajay Deshmukh Ajay Khedkar QC Manager QA manager Regulatory Affair PL Developments Ingenus Pharmaceutical Umedica Laboratories Pvt Ltd Clinton, SC, United States Navi mumbai, Non-US, India Mumbai, Non-US, India [email protected] [email protected] [email protected]
Ajay Pazhayattil Ajay Taluja ajit reddy Associate Director Staff Fellow Sales Apotex FDA mettler toledo Toronto, Non-US, Canada Silver Spring, MD, United States Hyderabad, Non-US, India [email protected] [email protected] [email protected] akash babber ALAN N[CHOLLS Albinus D'Sa Microbiologist Sr Advisor,Regulatory Affairs Special Assistance to the Office sgco COPPERHEAD CHEMICAL COMPANY INC FDA jubail, Non-US, Saudi Arabia TAMAQUA, PA, United States Silver Spring, MD, United States [email protected] [email protected] [email protected]
Alejandra Gómez Alice Hoffmann Alicia Fitzpatrick Project Leader Head of Quality Assurance GMP EHS Regulatory Manager Laboratorios PiSA Eurofins BioPharma Product Testing The Dow Chemical Company Guadalajara, Non-US, Mexico Munich GmbH Bristol, PA, United States [email protected] Planegg/Munich, Non-US, Germany [email protected] [email protected] Allen Che Allison Aldridge allison bonnenburg senior scientist Team Leader Regulatory Counsel Tetraphase Pharmaceuticals FDA FDA Watertown, MA, United States Silver Spring, MD, United States Silver Spring, MD, United States [email protected] [email protected] [email protected]
Allison Murdza Alvin Negron Amanda Rennig Process Development Intern Technical Consultant Senior QA/QC Associate Merck DGF Group Digestive Care, Inc Lexington, MA, United States San Juan, Non-US, Puerto Rico Easton, PA, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Amar Edlaher Ambrose Stafford Amidhepuram Sudheer Chief Compliance Officer Founder Sr. Manager American Pharmaceutical Ingredients, LLC Stafford Pharma Consulting, LLC Hetero drugs Boca Raton, FL, United States Hillsborough, NJ, United States Hyderabad, Non-US, India [email protected] [email protected] [email protected]
Amit Dumpawar Amy Blevins Amy Ganden Senior Executive Quality & Regulatory Specialist QA & Methods Compliance, Manager Wockhardt Limited India Kenco Logistic Services, LLC Particle Technology Labs Aurangabad, Non-US, India Chattanooga, TN, United States Downers Grove, IL, United States [email protected] [email protected] [email protected]
Amy Haataja Ana Padilla Anais Valencia Quality Assurance Supervisor Technician Laboratory MAnager Perrigo Inke, S.A. Henry Jackson Foundation/MHRP New Hope, MN, United States Castellbisbal, Non-US, Spain Silver Spring, MD, United States [email protected] [email protected] [email protected]
Andra Bene Andres Rivas Andrew Asirvatham Site Quality Engineer Engineering and Projects Director Quality Assurance Celestica Romania SRL Laboratorios PiSA SA de CV caplin point laboratories Oradea, Non-US, Romania Guadalajara, Non-US, Mexico Chennai, Non-US, India [email protected] [email protected] [email protected]
Andrew Hooper Anees Moosa anelis aurand araos Director Commercial Manufacturing Retail pharmacist Director, Scientific Affairs Retrophin, Inc. Private WellSpring Pharmaceutical Corporation San Diego, CA, United States Johannesburg, Non-US, South Africa Sarasota, FL, United States [email protected] [email protected] [email protected]
Angela Hughes Angelica Rivas Angella Silye QC Manager Quality Director Study Manager SPI Pharma MediStem Panama Inc Taro Pharmaceuticals USA Lewes, DE, United States Panama, Non-US, Panama Hawthorne, NY, United States [email protected] [email protected] [email protected]
Anirudh Ramachandran Ann Howard Anna Long Consultant Reg Assoc Attorney Ernst & Young,LLP igi labs Dean, Mead, Egerton, Bloodworth, Mumbai, Non-US, India Buena, NJ, United States Capouano &Bozarth, P.A. [email protected] [email protected] Orlando, FL, United States [email protected] Anne Armstrong Anne Kuan Annette Dunn QA & Compliance Mgr Drug Store, Pets and VP Reg CEO Consumables Neovii Coda Corp USA Meijer, Inc. Waltham, MA, United States Fairport, NY, United States Grand Rapids, MI, United States [email protected] [email protected] [email protected] Annia Diggs Anshuman Saran Antonio Soto QAQC Specialist Head CQA Handy Solutions Business Director Johns Hopkins Univ. SOM / CPGT Strides Arcolab Limited Navajo Manufacturing Co. Inc. Baltimore, MD, United States Bangalore, Non-US, India Denver, CO, United States [email protected] [email protected] [email protected]
Anuj Patel Anush Perikhanyan April Griggs Quality assurance QA Manager Compliance Management Unit Director Intas pharmaceutical limited DarmanTest Laboratories WRAIR, Viral Diseases Branch Ahmedabad, Non-US, India Yerevan, Non-US, Armenia Silver Spring, MD, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Archana Shekher Arenia Chavez Arianne Bouchard-Gagnon Consultant assistant chemical chemist QA associate Consultant Astecal Sac Nuvo Research Morrisville, NC, United States Lima, PA, Peru Varennes, Non-US, Canada [email protected] [email protected] [email protected]
Arshad Ali Arthur Fabian Artur Shchukin Incharge Compliance Cell President RC Specialist Zafa Pharmaceutical Laboratories (Pvt.) Ltd Fabian API Consulting LLC AMPAK KARACHI, Non-US, Pakistan Parsippany, NJ, United States New York, NY, United States [email protected] [email protected] [email protected]
ARUN THANGAVELU Arvind Bhalerao Asheley Pankratz OPERATIONS ENGINEERING SPECIALIST Director-Operations Senior Paralegal CELESTICA Orit Laboratories LLC American Pharmaceutical Ingredients, LLC TORONTO, Non-US, Canada West Caldwell, NJ, United States Boca Raton, FL, United States [email protected] [email protected] [email protected]
Ashlee Janusziewicz Ashley Boam Ashok Kumar Boyapati Consumer Safety Officer Director (A), Ofc of Policy for Officer FDA Pharmaceutical Quality Raks pharma Pvt Limited Silver Spring, MD, United States FDA/CDER Visakhapatnam, Non-US, India [email protected] Silver Spring, MD, United States [email protected] [email protected] Asma Ather Atul Sakariya Audrey Zaweski Documentation Specialist Corporate Quality President Xttrium Laboratories Sun Pharmaceutical Industries Limited Peconic Regulatory Consulting LLC Mount Prospect, IL, United States Vadodara, Non-US, India Calverton, NY, United States [email protected] [email protected] azaweski@peconicregulatoryconsultingllc. net Aurelis Cosme Avia Toney B R Reddy Chemist- Quality Control Vice President of Quality Assurance and Director-Operations Gasco Industrial Regulatory Affairs Natco Pharma Ltd Gurabo, Non-US, Puerto Rico GeNO LLC Hyderabad, Non-US, India [email protected] Cocoa, FL, United States [email protected] [email protected] Baban Bhalerao Babu Lad Bahrudin Kapo Sr. Officer Dir. Regulatory Affairs QAS Supervisor EnEm Nostrum Remedies Pvt. Ltd. Pharmaceuticals Belcher Pharmaceutical Mumbai, Non-US, India Parsippany, NJ, United States Largo, FL, United States [email protected] [email protected] [email protected] bala kumar Bala Nagisetti balakrishna Nunna Associate - Regulatory Affairs QA-Manager Dy. Manager -RA Shasun Pharmaceuticals Limited Sciegen Pharmaceuticals Inc Bioplus lifesciences pvt limited Puducherry, Non-US, India Hauppauge, NY, United States bangalore, KS, India [email protected] [email protected] [email protected]
Bangon Longsomboon Barbara Hach Barbara Thorne Regulatory Manager QA Manager Executive Director Pr Dev. University of Miami, Miller School of Cosmax USA Celladon Medicine Solon, MA, United States Seattle, WA, United States Miami, FL, United States [email protected] [email protected] [email protected] Barry Goodwin Becky Nortz Ben LU COO Associate Director, Regulatory Affairs VP, Quality ONY, Inc. New Haven Pharmaceuticals Sagent China Pharmaceuticals Amherst, NY, United States North Haven, CT, United States Chengdu, Non-US, China [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Benjamin Cordova Benjamin Do Benjamin Kraus Chemist Regulatory Affairs Coordinator Auditor for Medical Devices Thibiant Internationl Diamond Wipes International Strauss Medizintechnik Chatsworth, CA, United States Chino, CA, United States Bochum, Non-US, Germany [email protected] [email protected] [email protected]
Benjamin Stevens Bernadette De Leye Beth Carr Chemistry Reviewer Quality Excellence Coach Pharmacist FDA STEXCON FDA/CDER White Oak, MD, United States Haasrode, Non-US, Belgium Silver Spring, MD, United States [email protected] [email protected] [email protected]
Betty Jo Lorenz BETTY LLANA Beverly Folmer VP, Quality & Regulatory Inspector GMP Manager, Pharmaceutical Development Bell Pharmaceuticals, Inc. MINISTRY OF HEALTH DIGEMID PERU Incyte Belle Plaine, MN, United States LIMA, Non-US, Peru Germantown, MD, United States [email protected] [email protected] [email protected]
Bhagwan Chaudahry Bhagyashree Bhargave Bhim Bahadur Chaudhari Research Analyst Senior Group Leader Research Sunidhi Securities Strides Arcolab Limited UIPS,Panjab University Mumbai, Non-US, India Bangalore, Non-US, India chandigarh, Non-US, India [email protected] [email protected] [email protected] bipin kumar bipin kumar Blanca Zabala Audit and Compliance Audit and Compliance Pharmacy staff wockhardt wockhardt N/A Aurangabad, Non-US, India Aurangabad, Non-US, India Miami, FL, United States [email protected] [email protected] [email protected]
Bob MacDonald Bobae Kim Brandi Adoff Vice President, Regulatory Affairs VP Quality, Regulatory, Clinical Affairs Director Regulatory Affairs Scientific & Regulatory Consultants, Inc. Iluminage Beauty Inc. Vensun Columbia City, IN, United States New York, NY, Canada Yardley, PA, United States [email protected] [email protected] [email protected]
Brian Mabie Brian Newton Brittany Ann Medeo Pharmacist-in-Charge Head of Risk & Regulatory Affairs Compliance Consultant American Pharmaceutical Ingredients, LLC PROTein Biotechnologies Inc QACV Consulting Waterford, MI, United States Ramona, CA, United States Bethlehem, PA, United States [email protected] [email protected] [email protected]
Brooke Yakatan Caprice Bearden Caption Colorado Director, QA & Regulatory Director of Compliance Captioner IriSys LLC Pharmakon Pharmaceuticals Caption Colorado San Diego, CA, United States Noblesville, IN, United States Greenwood Village, CO, United States [email protected] [email protected] [email protected]
Carla Silva Carlos Amaro Carlos Martin Mayma A. RA analyst Technical Director Regulatory assesor Aché Laboratórios Farmacêuticos Inmed Per{u S.A.C. DIGEMID Guarulhos, Non-US, Brazil Lima, Non-US, Peru LIMA, Non-US, Peru [email protected] [email protected] [email protected]
Carlos Montoyo Carlton Rhames Carmen Kelly Senior Consultant QA Supervisor Consumer Safety Officer DGF Group Capstone Nutrition FDA San Juan, Non-US, Puerto Rico Spring Hill, TN, United States Silver Spring, MD, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Carmen Janneth Rivera Palacin Carol Marchione Carolina Geraldo Químico Farmaceutico VP, Reg Affairs and QA Assessor Farmacêutico Drección General de Medicamentos, TetraLogic Pharmaceuticals Aché Laboratórios Farmacêuticos S.A. Insumos y Drogas DIGEMID Malvern, PA, United States São Paulo, Non-US, Brazil Lima, Non-US, Peru [email protected] [email protected] [email protected] Catherine Johnson Catherine Mastrorilli Catrina Montgomery HLS Regulatory Lead Assistant Scientist GCP Coordinator WIpro Janssen R&D Romark Labortories Highland Park, IL, United States Malvern, PA, United States Tampa, FL, United States [email protected] [email protected] [email protected]
Celeste Goddard Celia Hernandez Cesar Burgos Regulatory Affairs Specialist Manager QC Tech Merz North America Laboratorios Pisa SA de CV SHL Pharma Raleigh, NC, United States Jalisco, Non-US, Mexico Boca Raton, FL, United States [email protected] [email protected] [email protected]
Chakrapani Kambhampati chander kazipeta CHANDRA SHEKAR GUMPALLY MANAGER Head - Global Regulatory Affairs Assistant Manager MYLAN airis PHARMA Dr.Reddys Laboratories Limited VISAKHAPATNAM, Non-US, India Hyderabad, Non-US, India Hyderabad, Non-US, India [email protected] [email protected] [email protected] chandrasahker akula Chang Lee changguang wang Manager Validation Sr. Dir, RA/CA scientist AMRI Capsugel UTSW Albany, NY, United States Morristown, NJ, United States DALLAS, TX, United States [email protected] [email protected] [email protected]
Chantal Joly Chantal Pare Charan Behl quality specialist (consultant) QA Manager Manager Telesta Therapeutics Inc. Nuvo Research Inc. PAC Pharmaceuticals, LLC Pointe-Claire, Non-US, Canada Varennes, Non-US, Canada Far Rockaway, NY, United States [email protected] [email protected] [email protected]
Charles Celeste Charles DiTusa Chaudhry Tajammal Hussain Director, Regulatory Pollicy & Intell Quality Assurance Quality Systems and Standards Lead Leo Pharma USAMMDA Novartis Pharma Parsippany, NJ, United States Ft. Detrick, MD, United States Karachi, Non-US, Pakistan [email protected] [email protected] [email protected]
Chee Kean Ong Chelsea Cabral Chethan Jungir Senior QRA Manager chemist research and development Celestica Malaysia Sdn. Bhd. Queen's Medical Center Biocon research labs Kulim, Non-US, Malaysia Honolulu, HI, United States Bangalore, Non-US, India [email protected] [email protected] [email protected]
Chi Vo chong kim Chris Fowler R&D Manager CMC Reviewer Member Nuvo Research Inc. OLDP/OPQ/CDER Chris Fowler, LLC Varennes, Non-US, Canada Silver Spring, MD, United States Newtown, CT, United States [email protected] [email protected] [email protected]
Chris Goodpaster Chris Holshouser Chris Jacques Quality Control Microbiologist Owner Sr. Manager ISTO Technologies GH Quality Consulting Corium International, Inc. Ollivette, MO, United States Wilmington, NC, United States Grand Rapids, MI, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Chris Wubbolt Christina Thompson Christine Hendricks President & CEO QA Quality Assurance Group Leader QACV Consulting, LLC Alvix Laboratories Consumer Product Testing Company Bethlehem, PA, United States Ocean Springs, MS, United States Fairfield, NJ, United States [email protected] [email protected] [email protected]
Christine Miller Christopher Smith Chunli Zhao VP Regulatory Affairs President QA Director TherapeuticsMD Coastal Pharmaceutical Consultants, Inc. Asychem Lab. Boca Raton, FL, United States Burgaw, NC, United States Tianjin, Non-US, China [email protected] [email protected] [email protected] m Cici Lu Cindy Lumbert Cindy Martin RA Quality Compliance Manager Director, Regulatory Affairs Yaopharma Co., Ltd. Lakeshore Technologies Aerie Pharmaceuticals, Inc. Chongqing, Non-US, China Norton Shores, MI, United States Irvine, CA, United States [email protected] [email protected] [email protected]
Cinzia Romero Claire German Colleen Johns Pharmacist Project Coordinator Regulatory Affairs MINSA PERU FDA Sancilio and Company Lima, Non-US, Peru Rockville, MD, United States Riviera Beach, FL, United States [email protected] [email protected] [email protected] congbiao mei CONSUELO LI Corrine Knight senior group leader PHARMACIST EVALUATOR Director of Business Initiatives united therapeutics DIGEMID Coda Corp USA silver spring, MD, United States lima, Non-US, Peru Fairport, NY, United States [email protected] [email protected] [email protected]
Creighton Tuzon Cris Lebrilla Crystal Gabriel Research Associate Director of Quality Assurance Sr Process Tech USC C3 Jian, Inc. SHL-Group Los Angeles, CA, United States Marina del Rey, CA, United States Deerfield Beach, FL, United States [email protected] [email protected] [email protected]
Dale Allen Dan Bigman Dan Wunderlich Associate Director VP of Quality Director QA/RA Dynport Vaccine Company, CSC-GS Gasco Industrial WellSpring Pharmaceutical Canada Frederick, MD, United States Gurabo, Non-US, Puerto Rico Oakville, Non-US, Canada [email protected] [email protected] [email protected]
Daneris Fernandez Daniel Gastelu Daniel Kashiwagi CEO President Researcher DGF Group Health Product Business Success LLC Prati-Donaduzzi San Juan, Non-US, Puerto Rico Sparta, NJ, United States Toledo, Non-US, Brazil [email protected] [email protected] [email protected]
Darrin Hofer DARSHAN THAKKAR datta tupepatil Compliance Manager REGULATORY OFFICER manager Conair Corporation sTEPUP PHARAMATECH UMEDICA LABORATORIES PVT LTD Rantoul, IL, United States AHMEDABAD, Non-US, India mumbai, IN, India [email protected] [email protected] [email protected]
David Hernandez David Jara David Beristain Director, Regulatory Affairs QA Associate Manager Chemo Group Xttrium Labs Proquina/Bayer Chatham, NJ, United States Mt. Prospect, IL, United States Orizaba, Non-US, Mexico [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information David Ferch David Kuchta David Lin Operations Manager QA Mgr. Senior Consultant Valjean Corporation QuadPharma LLC Biologics Consulting Group Indian Harbour Beach, FL, United States Clarence, NY, United States Potomac, MD, United States [email protected] [email protected] [email protected] david mcfarland David Meredith David Pereira editor Quality Supervisor Director of Operations fda webview Kenco Logistics Afton Scientific / AnovaFill camp hill, PA, United States Chattanooga, TN, United States Charlottesville, VA, United States [email protected] [email protected] [email protected]
David Swain david zhao Davina Marano Vice President, Regulatory Affairs Sr. VP Regulatory Counsel Scientific & Regulatory Consultants, Inc. Prinbury Biopharm FDA/CDER/OC Columbia City, IN, United States Pudong, Non-US, China Silver Spring, MD, United States [email protected] [email protected] [email protected] dawn spooner Deana Kaye Debaleena Bandopadhyay regulatory affairs President and Principal Medical Writer II Regulatory Associate perkinelmer DBL Clinical Associates, Inc. Astex Pharmaceuticals waltham, MA, United States Durham, NC, United States Pleasanton, CA, United States [email protected] [email protected] [email protected]
Debashis Chakraborty Debashish Panda Debbie Gumpert Manager-QA Head Quality Regulatory Specialist II Raks Pharma Pvt.Ltd. Naprod Life Sciences Albemarle Corporation Visakhapatnam, Non-US, India Mumbai, Non-US, India South, MI, United States [email protected] [email protected] [email protected] debolina sen roy Deborah Formelio Debra Dow student Clinical Quality Manager President pes college of pharmacy Romark Laboratories, L.C. Dow Development Laboratories, LLC bengaluru, Non-US, India Tampa, FL, United States Petaluma, CA, United States [email protected] [email protected] [email protected]
Debra Lehnus Delaram Moshkelani Delphine MERCIER QA/Regulatory Manager Review Chemist Quality team member Prestige Packaging FDA MEDINCELL Fort Myers, FL, United States Silver Spring, MD, United States Jacou, Non-US, France [email protected] [email protected] [email protected]
Denis Seungryum Kim Denise Ekstrom Dequan Zhu Intellectual Property Associate RA Manager Operation Director Celltrion Pharm DVC Shuang Bei Medical Group Cheong Ju, Non-US, South Korea Frederick, MD, United States Tianjin, Non-US, China [email protected] [email protected] [email protected]
DERAJRAM BENIVAL Derry Spragion devender Malhotra Manager (Corporate R & D) Scientist Sr.Executive HLL Lifecare Limited Catalent Pharma Solutions Solrex Pharmaceuticals Company Trivendrum, Non-US, India Morrisville, NC, United States baddi, Non-US, India [email protected] [email protected] [email protected] m Devendra Chavan DHARMESH PATEL Dhiren Bhatt Senior Research Scientist Head Regulatory Affairs Deputy General Manager Colgate Palmolive India Limited Atul Limited Wockhardt Ltd. Mumbai, Non-US, India Valsad, Non-US, India Aurangabad, Non-US, India [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Diallo Mamadou Diana Baronian Diana Lozano President Sr. Quality Specialist QA Compliance Diallo Global CMC Guthy|Renker LLC Gilead Sciences, Inc. Attleboro, MA, United States Santa Monica, CA, United States San Dimas, CA, United States [email protected] [email protected] [email protected]
Diana Parra Dilip Parikh Dimple Bommanaboina Student President Regulatory Affairs Student DPHARMA GROUP INC. Citron Pharma LLC Pittsburgh, PA, United States ELLICOTT CITY, MD, United States East Brunswick, NJ, United States [email protected] [email protected] [email protected]
Dinesh Kumar Dipa Ramolia Dipenkumar Patel Regulatory Counsel Sr. Manager, Quality Senior Associate, Regulatory Affairs FDA LEO Pharma Inc. Granules USA, Inc. Silver Spring, MD, United States Parssippany, NJ, United States Parsippany, NJ, United States [email protected] [email protected] [email protected]
Dnyaneshwar Gawade Dominick DiPaolo Donato Barbato Manager Training & Developement SVP Quality, Compliance & Regulatory Researcher Sun Pharmaceutical Industries Ltd. Tris Pharma Advanced accelerator applications Dewas, Non-US, India Monmouth Junction, NJ, United States Turin, Non-US, Italy [email protected] [email protected] [email protected]
Donna Brandt Donna Roney Dorcas Taylor Quality Control Manager Manager Consumer Safety Officer Cosmetic Laboratories of America Pfizer FDA Chatsworth, CA, United States Richmond, VA, United States Silver Spring, MD, United States [email protected] [email protected] [email protected]
Doris Ng Doris Ogrowsky Dorothea Murray Regional Quality System Manager Consultant Director of Chemical Research and Product Celestica Asia Regylatory Specialists Analysis Singapore, Non-US, Singapore St. Louis, MO, United States American Pharmaceutical Ingredients [email protected] [email protected] Boca Raton, FL, United States [email protected] Dorothy Guidry Doug Shaw Douglas Kline Director of Quality Director of CSV & IT Consulting Principal Capstone Nutrition-TN Azzur Group Douglas Kline UG (haftungsbeschraenkt) Spring Hill, TN, United States Annapolis, MD, United States Berlin, Non-US, Germany [email protected] [email protected] [email protected]
Dr. Matthias Grathwohl Dragana Males Dumbala Shashikanth Reddy Head of Quality Management Medical Director Quality Manager Swiss Caps AG ADAMIS PHARMACEUTICALS Zhejiang Jiuzhou Pharmaceuticals Ltd Kirchberg, Non-US, Switzerland CORPORATION Taizhou, Non-US, China [email protected] San Diego, CA, United States [email protected] [email protected] Durgaprasad Erukulla Dwight Edghill Eberth Leopoldo Sarmiento Infantes Officer-Regulatory affairs QA Lead EVALUATOR Mylan Horizon Pharmaceuticals' Inc. DIRECCIÓN GENERAL DE MEDICAMENTOS hyderabad, Non-US, India Riviera Beach, FL, United States INSUMOS Y DROGAS DEL PERÚ [email protected] [email protected] LIMA, Non-US, Peru [email protected] Eddie Liu Edmund Mickunas Eduardo Maldonado TS senior director Principal Consutant Principal Officer Sunny pharmtech Regulatory Consulting EM Consulting Group Taoyuan, Non-US, Taiwan Centerville, MA, United States Guaynabo, Non-US, Puerto Rico [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Edward Patt EDWIN ESPINOZA GUTIERREZ Eileen Castillo Principal Consultant PHARMACIST QC Manager Edward Patt LLC DIGEMID A.I.G. Technologies, Inc Lenoir, NC, United States LIMA, Non-US, Peru Deerfield Beach, FL, United States [email protected] [email protected] [email protected]
Eileen Daloia Elaine Scheye Elangho Muthusamy Director Regulatory Affairs President Specialist Senior Registrar Crown Laboratories The Scheye Group Ltd. Rashid Hospital Johnson City, TN, United States Chicago, IL, United States Dubai, Non-US, United Arab Emirates [email protected] [email protected] [email protected]
Elena Violeta Mendoza Arevalo Elina N. Khachiyan Elisa Perdon ASISTENTE Regulatory Compliance Specialist Quality Assurance Directorf Ministerio de Salud PERU-DIGEMID AIC US Pharmaceutical Corporation LIMA, Non-US, Peru Framingham, MA, United States Decatur, GA, United States [email protected] [email protected] [email protected]
Elizabeth Jumet Elizabeth Mason Elizabeth Moyer Vice President Manager, Regulatory Affairs CEO Keystone Laboratories Haemonetics Corporation M/P Biomedical Consultants LLC Memphis, TN, United States Covina, CA, United States Mill Valley, CA, United States [email protected] [email protected] [email protected]
Elizabeth Noble Elizabeth Rita Gutierrez Valencia Elle Bard owner/consultant Practicing Paralegal Elizabeth P. Noble, Inc. Universidad Nacional Mayor de San HTC LLC Salisbury, NC, United States Marcos South Lyon, MI, United States [email protected] Lima, Non-US, Peru [email protected] [email protected] Ellen Camos Ellen Lindner Emily Tash Director Sr. Regulatory Affairs Specialist QA Manager ANI Pharmaceuticals University of Pennsylvania Precision Nuclear Raleigh, NC, United States Philadelphia, PA, United States Salem, VA, United States [email protected] [email protected] [email protected] enrique pernas Eoin Walsh Eric Song Manager ARD Director of Analytical Sciences Quality Director avevadds Coda Corp USA Sagent pharmaceuticas (China) Miramar, FL, United States Buffalo/Niagara, NY, United States Pharmaceuticals Co., Ltd. [email protected] [email protected] Chngdu, Non-US, China [email protected] Eric White Erica Weiss Erika Guzmán Sr. VP Regulatory Affairs Administrative Assistant QA System Manager Mission Pharmacal Company American Pharmaceutical Ingredients, LLC WellSpring Pharmaceuticals Boerne, TX, United States Boca Raton, FL, United States Sarasota, FL, United States [email protected] [email protected] [email protected]
Erin Achurch Esther Sur EunSeon Yang MQA Specialist QA/RA Coordinator Assistant manager Pfizer Iluminage Beauty Inc. Penmix Ltd. Saint Louis, MO, United States New York, NY, United States Seoul, Non-US, South Korea [email protected] [email protected] [email protected]
Eva Kabir Evangeline Raguindin Evin Aycicek Durak Chairperson R&D/Regulatory Affairs Manager R&D Senior Specialist Researcher BRAC university Diamond Wipes International, Inc. Biofarma Pharmaceutics Dhaka, Non-US, Bangladesh Chino, CA, United States Istanbul, Non-US, Turkey [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Farishta Barack Farzad Parsaie Fatih Karademir Researcher Chief Operating Officer, Quality Assurance Manager Maryland GeNO LLC ARGIS Ilac Co. Baltimore, MD, United States Cocoa, FL, United States Ankara, Non-US, Turkey [email protected] [email protected] [email protected]
Fei Cheng feifei liu Felix Morales Regulatory Affairs QA engineering Quality Assurance Supervisor Yiling Pharmaceutical Ltd Luye pharmaceutical Navajo Manufacturing Co. Inc. Shijiazhuang, Non-US, China Yantai, Non-US, China Denver, CO, United States [email protected] [email protected] [email protected]
FERNANDO VILCHEZ Fiona Gould Forest Ford pharmacist Regulatory Affairs Project Manager CSO sisol Quotient FDA peru, PA, Peru Edinburgh, Non-US, United Kingdom Silver Spring, MD, United States [email protected] [email protected] [email protected]
Frances King Francesca Knowles Francesca Minale QA Manager Quality Specialist President TopChem Pharmaceuticals Coda Corp USA AF Pharma Inc. Sligo, Non-US, Ireland Buffalo/Niagara, NY, United States Piscataway, NJ, United States [email protected] [email protected] [email protected]
Francisco Huerta Francois Perreault francy elguera Manager lab supervisor - chemistry area manager Laboratorios PISA SA de CV Galderma Medikids Guadalajara, Non-US, Mexico Montreal, Non-US, Canada Lima, Non-US, Peru [email protected] [email protected] [email protected]
FRANK PERRELLA Frantiescoli Dimer fray huamanyauri Project Manager Formulation Researcher DRA Jr Coordinator Peru FDA/CDER Instituto Vita Nova GSK Consummer Health Care Silver Spring, MD, United States Hortolandia SP, Non-US, Brazil Lima, Non-US, Peru [email protected] [email protected] [email protected] r frederick golec frederick morgan Frederick Simon Golec Jr PhD RAC president none President cmcregaff, llc lianyungang runzhong pharmaceutical CMCRegAff, LLC merion station, PA, United States co.ltd merion station, PA, United States [email protected] lianyungang，jiangsu，china, Non-US, [email protected] China Frida Alcala [email protected] Kaddu Gabriel Lebovic Manager Senior GMP Specialist Vice President of Regulatory Affairs Laboratorios PISA SA de CV USP Global Regulatory Consulting, Ltd. Guadalajara, Non-US, Mexico ROCKVILLE, MD, United States Warminster, PA, United States [email protected] [email protected] [email protected]
Gabriela Miranda Orr Gale Dykes Gamal Aberra Consultant Director of Security Sr Manager, Fermentation/Purification Regulatory Affairs External Consultant Endo Pharmaceutical DVC Vaccine LLC Minneapolis, MN, United States Rye, NY, United States Frederick, MD, United States [email protected] [email protected] [email protected] gaurav thakur gaus khan Geeta Routray officer senior vice president Manager-Corporate Regulatory Affairs dpcl Abon pharmaceuticals LLC Piramal Enterprises Limited ahmedabad, Non-US, India northvale, NJ, United States Mumbai, Non-US, India [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Geetanjali Jaguste George Chang George Cobos Sr. Manager Regulatory Affairs Pharmacologist QC Manager Lupin Pharmaceuticals Inc FDA Paramount Cosmetics, Inc. Baltimore, MD, United States Silver Spring, MD, United States Clifton, NJ, United States [email protected] [email protected] [email protected]
George Efthyvoulos George Waterhouse Georgina Lo QC Manager President GxP Compliance Manager GR BioPharm Compliance, Inc BioMarin Pharmaceuticals Foothill Ranch, CA, United States Dunn, NC, United States Novato, CA, United States [email protected] [email protected] [email protected]
Gina Guido-Redden GINA ROEBKE Giridhar Prasad Jangly COO EXECUTIVE ASSISTANT Regulatory Affairs Associate Coda Corp USA LNK INTERNATIONAL, INC. Dr. Reddy's Laboratories Inc. Buffalo/Niagara, NY, United States HAUPPAUGE, NY, United States Princeton, NJ, United States [email protected] [email protected] [email protected]
Girish Koni Gladys Martin Glenn Huang Chemist Regulatory Affairs Manager Principal Scientist Guardian Drug Company Romark Laboratories, LC Icon Bioscience, Inc. Dayton, NJ, United States Tampa, FL, United States Sunnyvale, CA, United States [email protected] [email protected] [email protected] gonzalo carranza GOPAL PATEL Govindaswamy Periyannan pharmacist Regulatory Affairs Specialist Group leader Corporate quality assurance digemid Navinta LLC Advinus Therapeutics Ltd. Lima, Non-US, Peru Ewing, NJ, United States Bengaluru, Non-US, India [email protected] [email protected] [email protected]
Gregory Pollieri Gregroy Burke Gunjan Vanarase Manufacturing Engineer Intern Self employed Sr. Manager, Corporate Quality and Celestica Inc. GBB, LLC Compliance Toronto, Non-US, Canada Saint Louis, MO, United States G&W Laboratories, Inc [email protected] [email protected] South Plainfield, NJ, United States [email protected] Guravaiah Nalajam habibeh mahboobi Hammad Ali Manager RPH Officer Regulatory Affairs Hisun Pharmaceutical ltd howard university hospital PharmEvo Pvt. Ltd. Taizhou, Non-US, China McLean, NV, United States Karachi, Non-US, Pakistan [email protected] [email protected] [email protected]
Hana Boudiaf Harikishan Komma Harish Cherivirala Regulatory Affairs Head _ Regulatory Affairs Sr. Manager Medincell Caplin Point Laboratories Limited Abon Pharmaceuticals Cambridge, MA, United States Chennai, Non-US, India Northvale, NY, United States [email protected] [email protected] [email protected] harish varma Harshitha Talluri Heather Dillon Formulation scientist Regulatory Affairs Associate Quality Training Specialist appcurelabs Appco Pharma Romark Laboratories, L.C. Hyderabad, Non-US, India somerset, NJ, United States Tampa, FL, United States [email protected] [email protected] [email protected]
Heather Gingerich Heather Pratt Heemin Rhee Regulatory Affairs Associate Manager, Regulatory & Clinical Affairs President Sun Pharmaceutical Industries, Inc. Macopharma Health Research International Bryan, IN, United States Duluth, GA, United States North Potomac, MD, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Heeyoung Park Helen Hao Helen Sun Sr. Manager, Regulatory Affairs Regulatory Affairs Manager Associate Director, Regulatory Affairs Turing Pharmaceuticals CSPC Zhongnuo Pharmaceutical Bausch New York, NY, United States (Shijiazhuang) Co., Ltd. Bridgewater, NJ, United States [email protected] Shijiazhuang, Non-US, China [email protected] [email protected] Helen Zhang Hemant Wedhane Henry Lapoint DMF Specialist Asst. Manager Operations Manager Hangzhou Zhongmei Huadong Ajanta Pharma Ltd Astecal Pharmaceutical Co., Ltd Bharuch, Non-US, India Lima, Non-US, Peru Hangzhou, Zhejiang, China, Non-US, China [email protected] [email protected] [email protected] Hezuo Zhao Himanshu Jain Hippolitus Odukwu QA Supervisor QA Manager, PDS Director of QA & Regulatory Affairs BrightGene Pharmaceutical Co.,Ltd. Contract Pharmaceuticals Limited Canada Angelini Pharma Inc. Suzhou, Non-US, China Mississauga, Non-US, Canada Gaithersburg, MD, United States [email protected] [email protected] [email protected]
Hira Shariq hira shariq hiren patel Sr. Executive Quality Control Sr. Executive QC QUALITY ASSOCIATE Getz Pharma Getz Pharma kashiv pharma Karachi, Non-US, Pakistan Karachi, Non-US, Pakistan BRIDGEWATER, NJ, United States [email protected] [email protected] [email protected]
Hiren Shah hirenkumar sonani Hirofumi Kawai General Manager Sr. Scientist I Manager Wockhardt ltd Kashiv Pharma LLC Kyowa Hakko Kirin Pharma, Inc. Ankleshwar, Non-US, India Bridgewater, NJ, United States Princeton, NJ, United States [email protected] [email protected] [email protected]
Hong Chen Hongfei Yue Hongmei Li vp of R&D chemist reviewer Yiling Pharmaceutical FDA FDA/CDER shijiazhuang, Non-US, China silver spring, MD, United States Silver spring, MD, United States [email protected] [email protected] [email protected]
Hu Haining hui zhang Ian Hardy Associate RA officer CMC Director Gilead Beijing Yiling Bio-engineering Technology TetraLogic Pharmaceuticals Shanghai, Non-US, China Co., Ltd Malvern, PA, United States [email protected] Beijing, Non-US, China [email protected] [email protected] Ilango Thangavelu Imtiyaz Ubharay Inigo Pfeiffer Functional Test developer Manager R&D-QA Director Pharma & Biomed Celestica Tris Pharma Inc. AmRuss Toronto, Non-US, Canada Monmouth Junction, NJ, United States Kernersville, NC, United States [email protected] [email protected] [email protected]
Inna Strakovsky Irene Banas Irene Ng Sr. Regulatory Affairs Specialist Regulatory Manager QA Manager University of Pennsylvania Delaval Manufacturing Celestica Electronics (M) Johor Sdn Bhd Philadelphia, PA, United States Bannockburn, IL, United States Johor, Non-US, Malaysia [email protected] [email protected] [email protected]
Irene Rao Isabel Cisneros Isabella Schmitt QRA Specilaist Regulatory Affairs Regulatory Affairs Associate Stanford Blood Center RGR Pharma Ltd Repros Therapeutics Palo Alto, CA, United States Windsor, Non-US, Canada The Woodlands, TX, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Ismahan Ugas Izabela Rejdych Jabid Lotero Clinical Trial Administrator Regulatory Affairs Manager Regulatory Affairs Anakyst NCI AAA Procaps S.A Rockville, MD, United States Saint Genis Pouilly, Non-US, France Barranquilla, Non-US, Colombia [email protected] [email protected] [email protected]
Jack Zheng Jacki O'Leary Jacob Berns Regulatory Affairs Regulatory Affairs Specialist Manager, Technical Affairs Ruby Pharma Ocular Therapeutix Interchem Corp Duluth, GA, United States Bedford, MA, United States Paramus, NJ, United States [email protected] [email protected] [email protected]
Jacob Wendling jacqueline crawford Jacques Mowrer Training Coordinator Manager, Quality Systems Director Analytical Development SPI Pharma Catalent Pharma Soluitions- RTP Threshold Pharmaceuticals Grand Haven, MI, United States Morrisville, NC, United States South San Francisco, CA, United States [email protected] [email protected] [email protected]
Jagdamba Prasad Jalal Jafri James Brown Manager CEO & President Senior regulatory manager Sigmapharm laboratories DS Technologies Goldbelt Raven LLC Bensalem, PA, United States Darien, CT, United States Frederick, MD, United States [email protected] [email protected] [email protected] james cox James Duffy James Kang Sr Analytical Chemist/ Lab Supervisor Supplier Quality Manager Manager Thibiant Perrigo Neo Kimchi Bio-Active, Inc. Chattsworth, CA, United States Minneapolis, MN, United States San Jose, CA, United States [email protected] [email protected] [email protected]
James Whitehead Jami Knight Janak Patel VP Quality and Regulatory Affairs Analytical Chemist AGM Quality Unit Reliable Biopharmaceutical Corp IGI Labs, Inc. Halcyon Labs Private Limited Saint Louis, MO, United States Buena, NJ, United States Ahmedabad, Non-US, India [email protected] [email protected] [email protected]
Jane xiang Janice Vu Janie Russell Manager of Product Development Quality control Regulatory Affairs Specialist Flavine North America, Inc EO products NIH Closter, NJ, United States San Rafael, CA, United States Bethesda, MD, United States [email protected] [email protected] [email protected]
Jannina Suxe Ramirez Jason Alba Jason Edwards Químico Farmaceutico Sr. Manager Domain Packaging Supervisor Dirección de Medicamentos Insumos y WIPRO IGI Laboratories, Inc. Drogas Irvine, CA, United States Buena, NJ, United States Lima, Non-US, Peru [email protected] [email protected] [email protected] Jason Gillette Javorka Gunic Jay Tanna VP of Regulatory Compliance QA Manager Associate Consultant Westminster Pharmaceuticals, LLC Evofem Inc EY Odessa, FL, United States San Diego, CA, United States Mumbai, Non-US, India [email protected] [email protected] [email protected]
Jaya Dhiman Dhiman Jayashree Patel Jean Crawford Corporate Quality Assurance Sr. Regulatory compliance associate QA/Medical Affairs Specialist Sentiss Pharma Pvt Ltd Teva pharmaceutical US Nostrum Laboratories Inc. Gurgaon, Non-US, India Pomona, NY, United States Kansas City, MO, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Jean Crawford Jeannine Ramsey Jeffrey Fenerty QA/Medical Affairs Specialist Consultant Executive Director of Sterile Compounding Nostrum Laboratories Inc Accurate Clinical Solutions Pharmalogic CSP Kansas City, MO, United States Wellington, OH, United States Bridgeport, WV, United States [email protected] [email protected] [email protected]
Jen Pendlebury Jena Strauss-Schoenberger Jeness Jose Dector, Regualtory Affairs Regulatory Affairs Associate Associate III- Regulatory Affairs Novadaq Technologies ISTO Technologies, Inc. sandoz Mississauga, Non-US, Canada St. Louis, MO, United States Princeton, NJ, United States [email protected] [email protected] [email protected]
Jenn Snodgrass Jennie Allewell jennifer chenault Director QC Labs Sr Director Regulatory Affairs QA PD Pharmatech Cambrex Corporation kppt Seymour, IN, Afghanistan East Rutherford, NJ, United States bloomington, IN, United States [email protected] [email protected] [email protected]
Jennifer Bakula jennifer chenault Jennifer Chmura Senior Quality Manager QA Quality Assurance Associate Akorn Pharmaceuticals kp pharmaceutical Pharmaceutics International, Inc. Lake Forest, IL, United States bloomington, IN, United States Hunt Valley, MD, United States [email protected] [email protected] [email protected]
Jennifer Fetterolf Jennifer Morgan Jennifer Morgan Sr. Manager, Quality Assurance Manufacturing Manager Manufacturing Manager Chiesi USA, Inc. Osiris Therapeutics, Inc. Osiris Therapeutics Cary, NC, United States Columbia, MD, United States Columbia, MD, United States [email protected] [email protected] [email protected]
Jennifer Sensenig Jennifer Sievers Jenny (Shun Yin) Fong Clinical Research Coordinator Quality Director Head of Compliance The Ohio State University Medical Center Apothecares Supply Hovione LLC Columbus, OH, United States Decatur, AL, United States East Windsor, NJ, United States [email protected] [email protected] [email protected] m JENNY RAO Jenny Steele Jeremy Richardson Regulatory Specialist Repack Specialist Complaint Coordinator Shenzhen Hepalink Pharmaceutical Ltd., Apotheca Supply, Inc. Telcare Medical Supply Co. Decatur, AL, United States Concord, MA, United States Shenzhen, Non-US, China [email protected] [email protected] [email protected] Jerilyn Spencer Jerry Brandewie Jessica Haas Quality Assurance Manager Consultant Assistant Quality Manager Horizon Pharmaceuticals, Inc. IBTS Powdersize, Inc. Riviera Beach, FL, United States Spring, TX, United States Quakertown, PA, United States [email protected] [email protected] [email protected]
Jessica VanKirk Jessica VanMeter Jessika Lima de Azevedo Chemist Sr. RA Specialist Quality Assurance Auditor Next Science, LLC Qualitest Prati Donaduzzi Ltda Jacksonville, FL, United States Huntsville, AL, United States Toledo, Non-US, Brazil [email protected] [email protected] [email protected]
Jessika Lima de Azevedo jhonathan israel gonzález acosta Jia Wang Quality Assurance Auditor asistente de producción QA Analyst Prati DOnaduzzi Ltda laboratorio medrock corperation S.A PuraCap Pharmaceutical LLC Toledo, Non-US, Brazil lima, Non-US, Peru South Plainfield, NJ, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Jianhua Tang Jieun Lee jigisha varia Manager Associate Senior Manager, Reg Affairs Dynport vaccine llc Celltrion Pharm Evenus Pharmaceutical Industries Inc Frederick, MD, United States Cheongju-si, Non-US, South Korea Princeton, NJ, United States [email protected] [email protected] [email protected]
Jillian Collins Jingran Lu Jinjie Hu Sr. QA Specialist regulatory speclist Senior Consultant Charles River Laboratories prinston pharmacutical BCG Charleston, SC, United States East Windsor, NJ, United States Alexandria, VA, United States [email protected] [email protected] [email protected]
Jinous Saeedi Jinseok Jeon Jitendra Parmar Sr.Specialist RA/QA General Manager Production Manager Irvine Pharmaceutical Services BCWorld Pharm. Co., Ltd. Bio-Pharm Inc. Irvine, CA, United States Seoul, Non-US, South Korea Levittown, PA, United States [email protected] [email protected] [email protected]
Jo Collins Joachim Troost Joan Fanis Manager, Quality Clinical Compliance Senior Associate Director QA Manager Sterile Forms Ora, Inc. Boehringer Ingelheim Rafarm S.A. Andover, MA, United States Ridgefield, CT, United States Athens, Non-US, Greece [email protected] [email protected] [email protected]
Joanne Marriott Joaquin Perez Joe Murphy Sr, VP Quality Manager Director, Combination Products Amerigen Pharmaceuticals Inc Laboratorios Pisa SA de CV Compliance Lyndhurst, NJ, United States Jalisco, Non-US, Mexico Janssen Pharmaceuticals [email protected] [email protected] Neuchatel, Non-US, Switzerland [email protected] Joel Selcher Joey Hu John F Ekpe Head of Regulatory Strategy Regulatory Affairs Manager, Clincal Chemistry Jazz Pharmaceuticals, Inc. CSPC Zhongnuo Pharmaceutical TUH Palo Alto, CA, United States (Shijiazhuang) Co., Ltd. Philadelphia, PA, United States [email protected] Shijiazhuang, Non-US, China [email protected] [email protected] John Kim John Lester John Maddalena VP Quality, Regulatory and Viligance IT & Facilities Manager Quality Director Pierre Fabre Pharmaceuticals, Inc. ImmunoScience, Inc Haemtech Biopharma Services Parsippany, NJ, United States Pleasanton, CA, United States Essex Junction, VT, United States [email protected] [email protected] [email protected]
John Metcalfe John Miller John Oberholtzer Senior Microbiology Reviewer VP US Compliance Senior Regulatory Affairs Manager FDA Fresenius Kabi Celerity Pharmaceuticals, LLC Silver Spring, MD, United States Lake Zurich, IL, United States Bartlett, IL, United States [email protected] [email protected] [email protected] john punzi john punzi Jon Beaver Director QA and Tech Affairs Dir QA/ TECH AFFAIRS Vice President of Quality Control chpa chpa Focus Laboratories, Inc. Wash, DC, United States washigton, DC, United States North Little Rock, AR, United States [email protected] [email protected] [email protected]
Jonas Kazmirczak jose brenis José Luis Correa Vásquez Analist of Supplier Qualification jefe de produccion EVALUATOR Prati Donaduzzi lab. Medrock corp. DIRECCIÓN GENERAL DE MEDICAMENTOS Toledo, Non-US, Brazil Lima, Non-US, Peru INSUMOS Y DROGAS DEL PERÚ [email protected] [email protected] LIMA, Non-US, Peru [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Joshua McCartney Joy Frestedt Joy Trepanier QA Auditor I President and CEO QA Manager Charles River Laboratories Frestedt Incorporated Hill Dermaceuticals Inc Charleston, SC, United States Saint Louis Park, MN, United States Sanford, FL, United States [email protected] [email protected] [email protected]
Joyce Frey-Vasconcells Joyce Nwangwa JS REDDY Regulatory Consultnat Sr. Quality Systems Specialist HEAD QUALITY Frey-Vasconcells Consulting, LLC Catalent Pharma Solutions HONOUR LAB LTD Sykesville, MD, United States Morrisville, NC, United States VISHAKAPATNAM, Non-US, India [email protected] [email protected] [email protected]
Juan He JUAN BOTANA Juan Gutierrez Senior Director, Pharmacometrics GMP-COMPLIANCE HEAD Manager BioPharma Services Inc. INKE Laboratorios Pisa SA de CV Toronto, Non-US, Canada BARCELONE, Non-US, Spain Jalisco, Non-US, Mexico [email protected] [email protected] [email protected]
Juan Manuel Reategui Torrejon Juan Olivares León Juan Zha Quimico Farmaceutico Head of Quality And Regulatory Affairs RA, deputy director Independiente Siemens Zhejiang Medicine Co., Ltd. Xinchang Lima, PA, Peru Lima, Non-US, Peru Pharma [email protected] [email protected] Xinchang, Zhejiang, Non-US, China [email protected] Judith Cohen Judith Samardelis Judy McMeekin Director Quality Global IT Quality and Compliance Staff Director, Medical Products and Particle Sciences Inc Astrazenca Tobacco Policy Bethlehem, PA, United States Gaithersburg, MD, United States FDA/ORA [email protected] [email protected] Silver Spring, MD, United States [email protected] Julia Griselda Sarmiento Julia Zhu Juliana Rodriguez EVALUADOR R&A Manager PHARMACIST DIGEMID Flavine DIGEMID LIMA, Non-US, Peru Shanghai, Non-US, China LIMA, Non-US, Peru [email protected] [email protected] [email protected]
Julie Gerlach Julienne Pearson JULIO CASTAÑEDA Clinical Division Director Regulatory associate FARMACEUTICO Compliance Insight Inc. Teva DIGEMID Fairfield, OH, United States Woodcliff Lake, NJ, United States LIMA, Non-US, Peru [email protected] [email protected] [email protected]
Julivet Nuñez Jun Gao Junle Ren Biotechnologist Director, Global Alliance Management Senior R&D engineer Medistem Panama Inc Sagent Pharmaceuticals, Inc. Yiling Pharmaceutical Ltd Panamá, Non-US, Panama Schaumburg, IL, United States Shijiazhuang, Non-US, China [email protected] [email protected] [email protected]
Justyna Mazur Jyothi Matharu Kaci Rosales QA/QC Manager VP, Quality Quality Assurance and Regulatory Affairs OHM Pharma, Inc. KP Pharmaceutical Technology I Specialist Mineral Wells, TX, United States Bloomington, IN, United States Allergy Laboratories, Inc. [email protected] [email protected] Oklahoma City, OK, United States [email protected] Kairon Nóbrega Riguete Kaitlyn Riffel KALYANI TAMMAREDDY Project Management Consultant, Scientific Consulting QUALITY SYSTEMS MANAGER Prati Donaduzzi Cardinal Health JOHNS HOPKINS UNIV Toledo, Non-US, Brazil Overland Park, KS, United States BALTIMORE, MD, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information kamal elsayed Kamal Negi Kamana Singh G M Quality Assurance NA innovation corporation LTD Sentiss Pharma Pvt. Ltd. NA Cairo, CA, Egypt Gurgaon, Non-US, India Chalfont, PA, United States [email protected] [email protected] [email protected]
Kandi Hall Karan Khairnar Karen Barmore Quality Assurance Manager Quality management System Compliance Team Leader NAMSA Wockhardt Ltd Colgate-Palmolive Northwood, OH, United States Aurangabad, Non-US, India Greenwood, SC, United States [email protected] [email protected] [email protected]
Karen Cui Karen Metcalfe Karen Rojas Tamata Biologist Director, Regulatory Affairs practicing NIH DVC universidad católica de santa maría Bethesda, MD, United States Frederick, MD, United States Arequipa, Non-US, Peru [email protected] [email protected] [email protected]
Karen Zimm Karin Au Karl Scott Associate Director CMC Reg Affairs QA and RA Specialist Senior Manager, Compliance Johnson & Johnson Scynexis Johnson & Johnson Titusville, NJ, United States Research Triangle Park, NC, United States Ratitan, NJ, United States [email protected] [email protected] [email protected]
Karm Chand Panday karoll Gonzalez Kartick Das QA Validation QS Compliance Analyst Manager, Audit & Assurance Celestica Stryker GlaxoSmithKline Bangladesh Ltd Singapore, Non-US, Singapore FT. Lauderdale, FL, United States Dhaka, Non-US, Bangladesh [email protected] [email protected] [email protected] kasaiah valaparla Kasinath Baratam Kate Fang RA Associate Sr. Executive-Regulatory Affairs Regulatory Affairs Specialist Novo Nordisk Raks Pharma Pvt. Ltd. Yung Shin Pharm. Ind. Co., Ltd. Bangalore, IN, India Vishakapatnam, Non-US, India Taichung, Non-US, Taiwan [email protected] [email protected] [email protected]
Katerina Kazakou Katherine DeHaven Katherine Seifert QA/QC Director QA Specialist President RAFARM Ultra Tab Laboratories Seifert & Associates Athens, Non-US, Greece Highland, NY, United States Ventura, CA, United States [email protected] [email protected] [email protected]
Katia Melnik Katie Dougherty Katie Jackson RA Specialist Principal Manager G Production Inc. Adjusta Consulting Avalere Health Baie d'Urfé, Non-US, Canada Maple Glen, PA, United States Washington, DC, United States [email protected] [email protected] [email protected]
Katie Keathley Katrina Smith Kaushik Patel QA Manager QA/QC Specialist Regulatory Affairs Associate II Nostrum Laboratories JHU Cell Processing and Gene Therapy Teva Pharmaceuticals Kansas City, MO, United States Facility Horsham, PA, United States [email protected] Baltimore, MD, United States [email protected] [email protected] Kaustubh Gavaskar Kay Mitchen Kazuyuki Atarashi VP, Quality and Regulatory Affairs Director of Regulatory Affairs Global Program Manager Bio-Pharm Inc Natural Immunogenics Corp MBL International Levittown, NJ, United States Sarasota, FL, United States Woburn, MA, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Keith Michels Keith Mills Kelly Garcia Operations Manager Director of Research and Research Analyst Analyst IGI Labs, Inc. Trillium Asset Management Pratidonaduzzi Buena, NJ, United States Boston, MA, United States Toledo, Non-US, Brazil [email protected] [email protected] [email protected]
Kelly Key ken nolan Kenneth Petersen Quality Assurance Manager Senior Advisor Regulatory Associate II Endo/Qualitest Pharmaceuticals USFDA Teva Pharmaceuticals Huntsville, AL, United States Silver Spring, MD, United States Horsham, PA, United States [email protected] [email protected] [email protected]
Kenny Rogge Kerri FitzSimmons Ketty Rocio Balabarca Padilla Reg Affairs and Quality Process Project Logistics Pharmacits Extension Healthcare CoreRx, Inc. DIGEMID Fort Wayne, IN, United States Clearwater, FL, United States Lima, Non-US, Peru [email protected] [email protected] [email protected]
Ketul Khamar Kevin Huang Khemraj Hirani Quality System Specialist Sr. Manager Director, Regulatory affairs and quality Purdue Pharma Kashiv Pharma assurance Cranbury, NJ, United States Bridgewater, NJ, United States University of Miami miller school of [email protected] [email protected] medicine Miami, FL, United States Khurram Khan Kim HuynhBa [email protected] Ezdebskimi.edu Regulatory Affairs Manager Executive Director Vice President Quality & Reg Compliance Blu Pharmaceuticals Pharmalytik Chartwell Pharmaceuticals Franklin, KY, United States Newark, DE, United States Congers, NY, United States [email protected] [email protected] [email protected]
Kimberly Grevera Kimberly Patterson Kimberly Stidd Regulatory Affairs Manager Associate Director QA Manager GeNO LLC WES Pharma, Inc. KP Pharmaceutical Cocoa, FL, United States Westminster, MD, United States Bloomington, IN, United States [email protected] [email protected] [email protected] kinjal joshi Kinjal Mehta Kinn Chan Sr. Manager-QA Associate - Regulatory Affairs Director Regulatory Affairs Sun Pharmaceutical Industries Ltd Sancilio & Company, Inc, Torrent Pharma Inc. Gurgaon, Non-US, India Mumbai, FL, India Kalamazoo, MI, United States [email protected] [email protected] [email protected]
KIRAN KOLHE Kirankumar Kota Kishore Addanki ASSOCIATE VP - RA Quality Auditor Assistant Manager MICRO LABS LIMITED Azbil Telstar India Pvt. Ltd., Mylan Laboratories LImited BANGALORE, Non-US, India Hyderabad, Non-US, India hyderabad, Non-US, India [email protected] [email protected] [email protected]
Korben Knudson krishna chilakamarthy Kristen Schroeder Project Specialist Associate Director OPERATIONS MANAGER RMC Pharmaceutical Solutions Sciegen Pharmaceuticals Vita Key Packaging, Inc. Longmont, CO, United States Hauppauge, NY, United States Riverside, CA, United States [email protected] [email protected] [email protected]
Kristen Snaguski Kristine Khurshudyan Kristine Khurshudyan Quality Assurance Associate Quality Specialist Quality Specialist Pierre Fabre Esco-Pharm Ltd. Esco Pharm Parsippany, NJ, United States Yerevan, Non-US, Armenia Glendale, CA, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Kwok Wu Lakshmikanth Maddela Lara Noah VP of Quality & RA Manager - Regulatory Affairs Director, Regulatory Affairs Yiling Pharmaceutical Ltd Daewoong Pharmaceutical Co. Ltd. Nexgen Pharma Shijiazhuang, Non-US, China hyderabad, Non-US, India Irvine, CA, United States [email protected] [email protected] [email protected]
Laura Kendrick Laura Lamas LAWRENCE EMERE Regulatory Specialist Quality Assurance Assistant Manager COMPLIANCE MANAGER American Health Packaging Pharmalabenterprises PREPHARM Columbus, OH, United States Miami, FL, United States EWING, NJ, United States [email protected] [email protected] [email protected]
Leah Choi leah kleyn Leanne Sleer Project Specialist QA Director Senior Medical Writer RMC Pharmaceutical Solutions geri-care pharm INC Research Longmont, CO, United States Brooklyn, NY, United States Washington, DC, United States [email protected] [email protected] [email protected] leo su Leona Saunders Leonard Krause manager Head of RA & QA President sunnypharmtech Curis FDA Connect, Inc. New taipei city, Non-US, Taiwan Lexington, MA, United States Eugene, OR, United States [email protected] [email protected] [email protected]
Levi Li li qiao Lijie Wang Regulatory Affairs VP Manager, Regulatory Affairs CSPC Zhongnuo Pharmaceutical Handa Pharmaceuticals Actavis (Shijiazhuang) Co., Ltd. Fremont, CA, United States Parsippany, NJ, United States Shijiazhuang, Non-US, China [email protected] [email protected] [email protected] Lily Cueva Narro Lin Ping Lin Sun farmaceutico research scientist Specialist of RA digemid Jiangsu Simcere Pharmaceutical Yiling Pharmaceutical Ltd LIma, Non-US, Peru Group,China Shijiazhuang, Non-US, China [email protected] Nanjing, Non-US, China [email protected] [email protected] Linda McGovern Linwood Rayford Lisa Murray Quality Assurance Manager Attorney Director of Operations SterRx LLC SBA Office of Advocacy Provenir Plattsburgh, NY, United States Washington, DC, United States Garnet Valley, PA, United States [email protected] [email protected] [email protected]
Lisa Poon-Chuk lisa tan Lisa Yin RA & PV Associate associate vp of scieces and regulatory Regulatory Affairs Citron Pharma, LLC. affairs Chengdu Easton Pharmaceutical Co., Ltd. East Brunswick, NJ, United States GPhA Chengdu, Non-US, China [email protected] washington dc, DC, United States [email protected] [email protected] Lori de los Reyes Lou Diorio Lourdes Montanez Sr. Manager, Global Regulatory Affairs, Prinicpal Regulatory Affairs Specialist Device LDT Health Solutions Neolpharma, Inc. Amgen wayne, NJ, United States Caguas, Non-US, Puerto Rico Thousand Oaks, CA, United States [email protected] [email protected] [email protected] Lucja Orzechowski Luis Carlos Moschetta LUIS VELASQUEZ Quality Assurance Auditor Supplier Qualification Team Leader licenciado en biología Lohmann Therapy Systems Prati, Donaduzzi & Cia Ltda LMB H.COLICHON S.A.C West Caldwell, NJ, United States Toledo, Non-US, Brazil lima, Non-US, Peru [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Luke Sadowski Ma Kaihua maha lakshmi Plant Manager Deputy Manager Regulatory Affairs Hill Dermaceuticals Zhejiang Huahai Pharmaceutical Co,. Ltd. RAKS PHARMA PRIVATE LIMITED Sanford, FL, United States Neijiang, Non-US, China Vishakhapatnam, Non-US, India [email protected] [email protected] [email protected] mahesh reddy jonnala mahmoud ghannam Maira Adzema research associate R&D Project leader Director Quality Assurance gland pharma limited Hikma pharmaceuticals IPM hyderabad, Non-US, India Amman, Non-US, Jordan Silver Spring, MD, United States [email protected] [email protected] [email protected] maithili golhar Majid Hasheminejad Malini Batheja complaint investigator President VP of Analytical R&D and Regulatory CMC PL Developments 4-1-1 Consulting Services, LLC Saptalis Pharmaceutical westbury, NY, United States York, PA, United States HAUPPAUGE, NY, United States [email protected] [email protected] [email protected]
Manikanta K Manish Bhatt Manish Sapkota DRA Executive Quality Manager Quality control officer Gland Pharma Limited Colgate Palmolive Alive Pharmaceuticals Hyderabad, IN, India Morristown, TN, United States Biratnagar, Non-US, Nepal [email protected] [email protected] [email protected]
Manjunathan Ranganathan Mankit Ho Marada Satyanarayana Microbiologist Senior Vice President Jr.Officer-Regulatory Affairs Caplinpoint Laboratories limited Kashiv Pharma, LLC Raks Pharma Pvt. Ltd. Chennai, TN, India Bridgewater, NJ, United States Visakhapatnam, Non-US, India [email protected] [email protected] [email protected]
Marcela Saad Marcela Spelz Marcia Howard President & Senior Consultant Project Coordinator Senior Director, Regulatory & Scientific MarcM Consulting Canada PiSA Farmaceutica Affairs Kitchener, Non-US, Canada Guadalajara, Non-US, Mexico Consumer Healthcare Products Association [email protected] [email protected] Washington, DC, United States [email protected] Marcy Wylie Margaret Choy Maria Consuelo Neyra Cabezudo Sr. Compliance Auditor EVP, Regulatory Affairs & Compliance Quimico Farmaceutico Catalent Pharma Solutions Pharmadax USA, Inc. DIGEMID- PERU Morrisville, NC, United States Irvine, CA, United States Lima, Non-US, Peru [email protected] [email protected] [email protected]
Maria Caturla Maria Ferreira Maria Isabel Quicano Velasquez Clinical Research Monitoring Specialist Quality Assurance Director Assistant Pharmacist University of Pennsylvania Laboratorios PiSA SA de CV QUIMFA PERU SAC Philadelphia, PA, United States Guadalajara, Non-US, Mexico Lima, Non-US, Peru [email protected] [email protected] [email protected]
Maria McGarry Mariam Shokralla Marianne Scheffler Founder project manager President biolicensure Egyptian Drug Authority Scheffler & Associates montclair, NJ, United States Rockville, MD, Egypt Carmel, NY, United States [email protected] [email protected] [email protected]
Marie Dorat Marietsy Pujol MARIO DEL TORO Principal Consultant/CEO Research Analyst Manufacturing Operations Director IPRF, LLC University of Miami Pisa Farmaceutica S.A de C.V. San Diego, CA, United States Miami, FL, United States Guadalajara, Jalisco, Non-US, Mexico [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Mariola Mier Marisol Rodriguez Marissa Cordo Executive Consultant QA and QC Manager Regulatory Affairs Associate Pharma Quality Europe Interquim S.A. de C.V. Teva Pharmaceuticals USA Mexico, Non-US, Mexico Cuautitlan Izcalli, Non-US, Mexico Horsham, PA, United States [email protected] [email protected] [email protected]
Maritza Marquez Maritza Sosa Jimenez Mark Hendrickson Document Specialist Quality and Compliance Dir Reg Sci Roche Tissue Diagnostics Prime Enterprises, Inc. GPhA Tucson, AZ, United States Miramar, FL, United States Washington, DC, United States [email protected] [email protected] [email protected]
Mark Mitcher Mark Wita Marla Tegtmeier VP Quality Assurance VP QA RA QA Cordinator ChemAid Laboratories Pharmaceutical Associates, LLC HP Enterprise Saddle brook, NJ, United States Tampa, FL, United States Des Moines, IA, United States [email protected] [email protected] [email protected]
Marta Lisiakiewicz Martine Poisson Marvin Garrett Research Associate Validation supervisor Vice President MedinCell Galderma Aerie Pharmaceuticals Jacou, Non-US, France Baie d'Urfé, Non-US, Canada Irvine, CA, United States [email protected] [email protected] [email protected]
Mary Bame Mary Clark Mary Foster Senior Specialist: Auditing and Document General Manager Managing Director Control PharmaGenetico Pharma Consulting - The Foster Group Mylan Pharmaceuticals San Antonio, TX, United States Blue Bell, PA, United States Greensboro, NC, United States [email protected] [email protected] [email protected] Mary Wood Marycarmen Nieto Marycarmen Nieto Regulatory/Quality Director QA Director of QA/RA BioConvergence Pisa-Biopharm Pisa Biopharm Bloomington, IN, United States Albany, NY, United States Albany, NY, United States [email protected] [email protected] [email protected]
Masayoshi Nishiyama MATHEW GEORGE MATILDE HUARI MARIN owner General Manager evaluador Nishiyama Consulting Office Cadila Healthcare Limited DIGEMID-MINSA Tokyo, Non-US, Japan Vadodara, Non-US, India Lima, Non-US, Peru [email protected] [email protected] [email protected]
Matt Cohen Matt Potter Maureen Kozuch Director of Technical Services QA Pharmacist Regulatory Manager SA Analytical Roadrunner Pharmacy Dow Chemical MUNDELEIN, IL, United States Phoenix, AZ, United States Midland, MI, United States [email protected] [email protected] [email protected]
Maurice Briggs Maya Kharawala Mayra Guzman-Kaslow Principal Director of Analytical/Quality President GMB Bio:Pharma Development Orit Laboratories LLC GK Regulatory Complaince & Enginering Harleysville, PA, United States West Caldwell, NJ, United States Consulting LLC [email protected] [email protected] West Palm Beach, FL, United States mguzmankaslow@gkregulatorycompliance Meena Surana Meenakshi Muthiah .comMeghan Heffernan Director, QA & RA Regulatory Operations Specialist Quality Control Supervisor Polygen Pharmaceutcials LLC DynPort Vaccine Company LLC IGI Labs, Inc. Edgewood, NY, United States Frederick, MD, United States Buena, NJ, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Mehul Gandhi Mehwish Saeed Meifang Jiang QA Manager Senior Executive Quality Assurance Director of Quality Control Lab NLI Documentation Xttrium Laboratories, Inc. Kansas City, MO, United States Scilife Pharma (Pvt.) Limited Mount Prospect, IL, United States [email protected] Karachi, Non-US, Pakistan [email protected] [email protected] Melissa Basnight Melissa McMichael Melody Tsai Director Regulatory & Quality Quality Assurance Auditor GMP Processing Supervisor LifeScience Logistics Alliance Pharma TissueTech, Inc Dallas, TX, United States Malvern, PA, United States Doral, FL, United States [email protected] [email protected] [email protected]
Michael Mackie Michael Ayeni Michael Barron QC Laboratory Supervisro QA Compliance Specialist Director Xttrium Laboratories Johnson Matthey Pharmaceutical Material Quality Chemical Laboratories Mount Prospect, IL, United States West Deptford, NJ, United States Wilmington, NC, United States [email protected] [email protected] [email protected]
Michael Beckelic Michael Boyd Michael Channing Manager, Quality and Regulatory Affairs Corporate Quality Assurance Auditor Radiochemist Sebela Pharmaceuticals Inc. Procter & Gamble National Institutes of Health Roswell, GA, United States CIncinnati, OH, United States Bethesda, MD, United States [email protected] [email protected] [email protected]
Michael Fountoulakis Michael Megargee Michael Ok Director, Quality Assurance Senior GMP Specialist Post-Doc AustarPharma, LLC U.S. Pharmacopeial Convention University of Wuerzburg Edison, NJ, United States Rockville, MD, United States Wuerzburg, Non-US, Germany [email protected] [email protected] [email protected]
Michael Powanda Michael Schwöppe Michele Desjardins President Project Manager CMO Quality Manager M/P Biomedical Consultants LLC tesa Labtec GmbH Galderma Mill Valley, CA, United States Langenfeld, Non-US, Germany Baie d'rUfé, Non-US, Canada [email protected] [email protected] [email protected]
Michelle Espiritu Michelle Saylor Michelle Yorke Senior CRC Product Compliance Scientist Sr. QC Manager Clinical Trial Network USAMMDA Biodel Inc. Houston, TX, United States Frederick, MD, United States Danbury, CT, United States [email protected] [email protected] [email protected]
Miguel Mercier Mike Dempsey Mike Kirkbride Deputy Director Manager of Quality Assurance VP Clinical Sanofi Pasteur PD Pharmatech American HomePatient` Toronto, Non-US, Canada Seymour, IN, United States Tampa, FL, United States [email protected] [email protected] [email protected]
Mike Yelvigi MILAGROS HEREDIA ALFARO milton pena Managing Partner CATALOGATION Pharmacist CPI Pharma DIGEMID Ministry Of Health Basking Ridge,, NJ, United States LIMA, Non-US, Peru Lima, Non-US, Peru [email protected] [email protected] [email protected] min chen Min Sik Shin Minerva Hughes Senior Manager, Regulatory Affairs Assistant Manager Branch Chief Ultragenyx Pharmaceutical Inc. BCWORLD PHARM FDA Novato, CA, United States Seoul, Non-US, South Korea Silver Spring, MD, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Miriam Montante Mitesh Bhadricha Mithun NM Residues Toxic Manager Consultant Senior Process Associate Laboratorio Central Regional del Norte EY TCS Guadalupe, Non-US, Mexico Mumbai, Non-US, India Pune, Non-US, India [email protected] [email protected] [email protected]
Mitsu Fink mitul patel MOGALI RAMBABU Quality Control Specialist asst manager Assistant General Manager-Regulatory Memorial Sloan Kettering Cancer Center sun Affairs New York, NY, United States vadodara, Non-US, India Raks pharma Pvt. Ltd [email protected] [email protected] Visakhapatnam, Non-US, India [email protected] Mohamad Amiruddin Mohamad Nor mohammad azad Mohammed Yousffi Supplier Quality Engineer technical manager Quality Assurance Auditor Celestica (M) Sdn Bhd healthcare pharmaceuticals limited Fresenius Kabi USA, LLC Johor Bahru, Non-US, Malaysia dhaka, Non-US, Bangladesh Melrose Park, IL, United States [email protected] [email protected] [email protected]
Mona Malhotra Montserrat Megías Na Rae Song Senior Manager Corporate Quality Regulatory Documentation Manager Business Developer Assurance INKE, S.A. Dong Sung World Wide USA, Inc. Sentiss Pharma Pvt. Ltd Castellbisbal, Non-US, Spain Cerritos, CA, United States Gurgaon, Non-US, India [email protected] [email protected] [email protected] Nadia Osman Naga Mahendar Velishala Nagaraj Reddy Clinical trial Coordinator Vice President Managing Director OSU Mirror Pharmaceuticals LLC Ascenders Consulting Services Columbus, OH, United States Fairfield, NJ, United States Bangalore, KS, India [email protected] [email protected] [email protected]
NAGARAJ TOLNOORKAR NAGARJUNA BHOGADI Naheed Sayeed QUALITY ASSURANCE REGULATORY AFFAIRS Manager, Process Validation, TO ALLURE LABS DAEWOONG PHARMA Apotex HAYWARD, CA, United States HYDERABAD, Non-US, India Toronto, Non-US, Canada [email protected] [email protected] [email protected]
Nancy Feng Nancy Lonnroth Nancy martin Regulatory Affairs Director Document Control Associate II CSPC Zhongnuo Pharmaceutical AMAG Nostrum Laboratories Inc. (Shijiazhuang) Co., Ltd. Derry, NH, United States Kansas city, MO, United States Shijiazhuang, Non-US, China [email protected] [email protected] [email protected] Nancy Muzik Nandkumar Chodankar Nanduri Venkata Ramana Kumar Associate Director, Quality Assessment CEO General Manager Shionogi Inc. ASolution Pharmaceuticals Pvt. Ltd SunPharma Industries Limited Alpharetta, GA, United States Mumbai, Non-US, India Gurgoan, Non-US, India [email protected] [email protected] [email protected]
Narendira Kumar Narendrasinh Gohil Nasrin Mehranmehr Senior Manager Quality Assurance Expert Orchid Healthcare Pharmaceutics International Inc Avicenna Research Institute Chennai, Non-US, India Hunat Valley, MD, United States Tehran, Non-US, Iran [email protected] [email protected] [email protected]
Naveen Yadav Nayaz Ahmed Neel Patel Sr. Executive Director Quality & PD Project Manager Megafine Pharma (P) Limited PrimaPharm.net Orit Laboratories LLC Nashik, Non-US, India San Diego, CA, United States West Caldwell, NJ, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information neha yadav NEHRU GADDIPATI Nestor Chihuan Regulatory affairs CEO Farmaceutico Daewoong Pharamceutical NINES CONSULT PHARMA Direccion de Medicamentos del Ministerio hyderabad, Non-US, India NEW YORK, NY, United States de Salud de Peru [email protected] [email protected] Lima, Non-US, Peru [email protected] Nicole Fisher Nicole Gallo Nicole Leonhardt RA Manager Consultant Quality Specialist DVC Halloran Consulting Group Dow Development Laboratories, LLC Frederick, MD, United States Boston, MA, United States Petaluma, CA, United States [email protected] [email protected] [email protected]
Nicole Motley Ninad Sheth Ningpu Yu Compliance Officer Supervisor Sr Scientist Hill Dermaceuticals Taro Pharmaceutical Neuralstem Inc sanford, FL, United States Brampton, Non-US, Canada Germantown, MD, United States [email protected] [email protected] [email protected]
Nipun Davar Nirav Sevak Nirvi Patel Senior VP. Pharm Dev. and Mfg Regulatory Affairs Specialist qa specialist II Threshold Pharmaceuticals Nostrum Laboratories Inc nostrum labs South San Francisco, CA, United States kansas city, MO, United States kansas city, MO, United States [email protected] [email protected] [email protected]
Nishant sharma Nishant Sharma Nola Mayo Regulatory and Compliance Specialist Regulatory and Compliance Specialist Regulatory Counsel 1987 Shield line LLC FDA HACEKENSACK, NJ, United States Hackensack, NJ, United States Silver Spring, MD, United States [email protected] [email protected] [email protected]
Norma Victoria Salazar Guillen Nrupa Patel Nur Hossain Pharmacist Research Scientist pharmaceuticals DIGEMID Navinta LLC Navana Pharmaceuticals limited Lima, Non-US, Peru Ewing, NJ, United States Dhaka, Non-US, Bangladesh [email protected] [email protected] [email protected]
Nurjehan Jivani Obaid Ali Olga Alfieri Corporate QA Compliance Auditor Federal Inspector of Drugs Assoc Director Symbio, LLC Drugs Regulatory Authority of Pakistan Eisai Fremont, CA, United States Karachi, Non-US, Pakistan Woodcliff Lakes, NJ, United States [email protected] [email protected] [email protected]
Olga Alfieri` Omprakash Koshti Onesmo Mpanju Associate Director Deputy General Manager Corporate Principal Consulting Eisai Quality LINQ Pharma Consulting Woodcliff Lake, NJ, United States SUN Phamaceutical Ltd. Aldie, VA, United States [email protected] Vadodara, Non-US, India [email protected] [email protected] orange zhang padmavathi rangisetty Pallavi Patil RA Senior Executive in Refairsgulatory Af Associate QA ZMC MSN Laboratories Limited Sancilio Pharmaceutical Pvt Ltd shaoxing, Non-US, China Hyderabad, Non-US, India Mumbai, Non-US, India [email protected] [email protected] [email protected]
Pallavi Shetty Pankaj Ingole Pankaj Kashyap Formulation R and D Formulation scientist Regulatory Affair Cronus research labs Pvt Ltd bright future , china Akorn India Private Limited Bangalore, Non-US, India Haikou, AL, China Gurgaon, Non-US, India [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Pankaj Patel PARINYA SUTHEERASAK PASCAL WONGBI Manager Pharmacist External QA Professional III Piramal Enterprises Limited HIV-NAT Perrigo Mumbai, Non-US, India Bangkok, Non-US, Thailand Minneapolis, MN, United States [email protected] [email protected] [email protected]
PASHUPATHINATH SIDDAMSHETTY Pat Stephens Patrice Powers-Feigel MANUFACTURING CHEMIST President/Owner Director Tech Ops SCIEGEN PHARMA INC Medi-Fare Drug Midas Pharmaceutical, Inc. HAUPPAUGE, NY, United States Blacksburg, SC, United States Parsippany, NJ, United States [email protected] [email protected] [email protected]
Patricia Amanqui Patricia Battonyai de Oliveira Patricia McDonald Especialist evaluation of pharmaceutical Quality Operations Director QA Administration product Bayer HealthcCare Capstone Nutrition DIGEMID Cleveland, TN, United States Spring Hill, TN, United States Lima, Non-US, Peru [email protected] [email protected] [email protected] Patricia Mendoza Patricia Paz Patricia Saulino Manager, Regulatory Affairs Regulatory Affairs Specialist Manager Medical Affairs Houston Methodist Research Institute GE Healthcare del Peru SAC Ascend Therapeutics Houston, TX, United States Lima, Non-US, Peru Herndon, VA, United States [email protected] [email protected] [email protected]
Patrick Neibergall paul cleary Paula Costa Vice President (QC/RA/DC) Head of Quality Regulatory Affairs Analisty Weeks & Leo Co., Inc. EirGen Pharma Prati Donaduzzi Clive, IA, United States Waterford, Non-US, Ireland Toledo, Non-US, Brazil [email protected] [email protected] [email protected]
Paula Costa Pavadi Subramaniam Pawan Kumar Garg analist Senior Manager Quality Dy. Manager Prati Donaduzzi OHM Labs Inc Biocon Limited toledo, Non-US, Brazil New Brunswick, NJ, United States Bangalore, Non-US, India [email protected] [email protected] [email protected]
Payal Saraf Peddanna Gumudavelli Peggy Cummings Consultant VP QA Certified Clinical Research Coordinator EY Appco Pharma LLC Lou Ruvo Center for Brain Health Mumbai, MS, India Somerset, NJ, United States Las Vegas, NV, United States [email protected] [email protected] [email protected]
Peipei Xu Peram Narayana peter perfito Group Leader Manager - Compliance production manager WuXi AppTec Sun Pharmaceuticals Industries Limited Endo Pharmaceutical Shanghai, Non-US, China Baddi, Non-US, India rye, NY, United States [email protected] [email protected] [email protected]
Phanindra Singh Philip Ashok Karunakaran phyllis sacks Associate Project Manager President - Technical QA External Ops 4C Pharma Solutions Caplin Point Laboratories Limited LEO Pharmaceutical Bangalore, Non-US, India Chennai, Non-US, India Parsippany, NJ, United States [email protected] [email protected] [email protected]
Pierre M. Eberst Pilar Pascual Ping Wang Head of QA Regulatory Affairs Manager principal scientist Galderma Spirig TIARE CONSULTING JNJ Egerkingen, Non-US, Switzerland Madrid, Non-US, Spain Malvern, PA, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Poonam Pande Postelle Birch-Smith Prachi Khandelwal Manager Consumer Safety Officer Manager Integrated CMC Solutions LLC FDA EY Chapel Hill NC, NC, United States Silver Spring, MD, United States Mumbai, Non-US, India [email protected] [email protected] [email protected] pradeep singh Prajakta Palshikar Pranav Sarvaiya Manager Drug Regulatory Affairs Manager - Regulatory Affairs Consultant Ipca Laboratories Ltd. Alpha MD Pvt Ltd EY Mumbai, Non-US, India Mumbai, Non-US, India Mumbai, Non-US, India [email protected] [email protected] [email protected]
PRASANNA K BHAT Prasanna Palle Prashant Vagadia Sr. Regulatory Specialist Regulatory Affairs Associate Executive iMED Global Amneal Pharmaceuticals Sun Pharmaceutical Industries Ltd. Bangalore, Non-US, India Hauppauge, NY, United States Vadodara, Non-US, India [email protected] [email protected] [email protected]
Prassanjit Dey Preston Grondahl priyal goyal Executive Quality Control Lead consultant Sun Pharmaceutical Industries Ltd. Guthy Renker Ernst and young Vadodara, Non-US, India Arden, NC, United States mumbai, Non-US, India [email protected] [email protected] [email protected]
Puiho Yuen Puja NAGPAL punit patel R&D, Product Development Post Doctoral Scientist Sr Manager Quality Control Dr. Reddy's Laboratories, Inc ICGEB PL Developments Princeton, NJ, United States delhi, Non-US, India Westbury, NY, United States [email protected] [email protected] [email protected]
Purvee Patel QunQun Decreny Rachel Tan student QA auditor Quality system specialist Temple University Alliance Pharma Shenzhen Salubris Pharmaceuticals Co., Philadelphia, PA, United States Malvern, PA, United States Ltd. [email protected] [email protected] Shenzhen, Non-US, China [email protected] Rachelle Ware Radha Ramesh RADHIKA KONDAPAKA Quality Control Head of Assurance for Life Sciences, NA Medical Monitor HP TCS The Emmes Corporation Des Moines, IA, United States Bridgewater, NJ, United States Rockville, MD, United States [email protected] [email protected] [email protected]
RAFAEL COMAS Raghavendra Rao varada Raghunandhan Painoori Regulatory Affairs Coordinator Asst. Manager Assistant Manager PROCAPS S.A. DR. REDDYS LABORATORIES Novel Laboratories, Inc. BARRANQUILLA, CO, Colombia Visakhapatnam, Non-US, India Monmouth Junction, NJ, United States [email protected] [email protected] [email protected]
Raghunath Chigurupati raghuram pannala Ragini Mehta Manager A.VP QA&RA Medical technologist-microbiolgy HeteroUsa Sciegen Pharmaceuticals NIH PISCATAWAY, NJ, United States Haupauge, NY, United States Bethesda, MD, United States [email protected] [email protected] [email protected]
RAJAN DESAI Rajan Dubey Rakesh Chaurasia Vice President Quality Director Procurement Head of Drug Regulatory Affairs OLIVE HEALTHCARE 3tfederal solutions llc PT DexaMedica MUMBAI, Non-US, India BHOPAL, Non-US, India Tangerang, Non-US, Indonesia [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Rakesh Lad ramakrishna sampathi Rambabu Mogali Vice President Regulatory Affairs Consultant Assistant.General Manager-Regulatory AptaPharma Inc Benta Pharma Industries Affairs Pennsauken, NJ, United States Beirut, Non-US, Lebanon Rakspharma.com [email protected] [email protected] visakhapatnam, Non-US, India [email protected] Rambabu Mogali Ramireddy chityala Ramon Genoves Assist.General Manager-Regulatory Affairs In-process Quality Assurence Quality manager Raks Pharma Pvt. Ltd caplin point laboratories ltd Celestica Valencia Visakhapatnam, Non-US, India chennai, Non-US, India Valencia, Non-US, Spain [email protected] [email protected] [email protected]
Ranjana Arote Raquel Otero Graubard Ratna Lingamaneni Sr. Manager Regulatory Affairs Quality Assurance & Regulatory Director Director, Regulatory Affairs Enaltec Labs Private Limited Amino Cell, Inc. AbbVie Thane, Non-US, India Fort Lauderdale, FL, United States North Chicago, IL, United States [email protected] [email protected] [email protected]
Raul Gonzales Ravi Chhatani Ravi Sankar Kothamasu Global Quality Manager Manager Manager - Intellectual Property Celestica Actavis Suven Life Sciences Limited New York, NY, United States Mumbai, Non-US, India Hyderabad, Non-US, India [email protected] [email protected] [email protected]
Ravi Srikanth Tallapragada Ravishankar Vadali rebecca cuniff Manager - QA Associate Director Senior Regulatory Affairs Mirror Pharmaceuticals Janssen R&D First Priority, Inc. Fairfield, NJ, United States Springhouse, PA, United States Elgin, IL, United States [email protected] [email protected] [email protected]
Rebekah Wood Reddy kal Renae Dixon Chemist Director, Quality Systems Assoc Director of Regulatory Affairs United therapeutics Fresenius Medical Care CPI Silver spring, DC, United States Ogden, UT, United States Fishers, IN, United States [email protected] [email protected] [email protected]
Renate Eggert Rene Flores Renita Johnson-Leva QA VP Operations Director Biotest DGF Group ABL Dreieich, Non-US, Germany San Juan, Non-US, Puerto Rico Rockville, MD, United States [email protected] [email protected] [email protected] renu gupta Renuka Yanamadala Rhonda Jones Principal Asst. Manager President Global Bio-Pharma Consulting Granules india limited Scientific & Regulatory Consultants, Inc. Moorestown, NJ, United States Hyderabad, Non-US, India Columbia City, IN, United States [email protected] [email protected] [email protected]
Richard Reeve rikinkumar gandhi Rita George Sr. Director R&D Quality Assurance Superviosr Quality Quality Control Manager Endo Yichang Humanwell OSD Plant KP Pharmaceutical Technology Inc. Malvern, PA, United States Yichang, Non-US, China Bloomington, IN, United States [email protected] [email protected] [email protected]
Ritesh Panjabi Ritesh Panjabi Robbie Scott Quality Assurance officer Officer-Quality Assurance Quality Coordinator Glenmark Pharmaceuticals Limited Glenmark Pharmaceuticals Ltd Kenco Logistics Mumabi, Non-US, India Mumbai, Non-US, India Chattanooga, TN, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Robert Bard Robert Eackles Robert Garcia Managing Director Product Compliance Scientist QA Director HTC LLC CRM Hill Dermaceuticals, Inc. Northville, MI, United States Frederick, MD, United States Sanford, FL, United States [email protected] [email protected] [email protected]
Robert Hauser Robert Iser Robert Kaster Executive Vice President Senior Scientific Advisor (acting) President Perosphere Inc FDA/CDER/OPQ/OPF RK Pharmaceutical Consulting LLC Danbury, CT, United States Silver Spring, MD, United States Glenmoore, PA, United States [email protected] [email protected] [email protected]
Robert Melo Robert Melo Robert Wolfangel President President VP Scientific Affairs OHM pharma inc OHM PHARMA INC Certus International Inc Mineral Wells, TX, United States Mineral Wells, TX, United States St. Louis, MO, United States [email protected] [email protected] [email protected]
Roberto Toledo Rock Chen Rolando Vega VP Sales & Marketing Regulatory Director sanitary authorizations - evaluator DGF Group Easton Pharmaceuticals MINSA - PERÚ San Juan, Non-US, Puerto Rico Chengdu, Non-US, China Lima, Non-US, Peru [email protected] [email protected] [email protected]
Rong Pan Roohi Obaid Rosa Guzman regulatory affairs specialist Deputy Drugs Controller Consultant Austarpharma LLC Drug Regulatory Authority of Pakistan DGF Group Edison, NJ, United States KARACHI, Non-US, Pakistan San Juan, Non-US, Puerto Rico [email protected] [email protected] [email protected]
Rosa Lugo Rosa Rivera Rosanna Fajar Compliance Consultant INSPECTOR Senior Research Worker DGF Group MINISTRY OF HEALTH OF PERU John Hopkins University/Columbia San Juan, Non-US, Puerto Rico LIMA, Non-US, Peru University [email protected] [email protected] New York, NY, United States [email protected] Rosario Luis Rose Zhao Roshni Patel Inspector Managing Director QA Supervisor DIGEMID Emprise Pharma LLC Supernus Pharmaceuticals Lima, Non-US, Peru Phoenixville, PA, United States Rockville, MD, United States [email protected] [email protected] [email protected]
Ross Velasquez Rowen Luna Roxanne Sisak Quimico Farmaceutico Senior Quality Engineer Quality Assurance Manager Direccion General de Medicamentos Fresenius Kabi USA J Knipper and Company, Inc. Insumos y Drogas Melrose Park, IL, United States Lakewood, NJ, United States Lima, Non-US, Peru [email protected] [email protected] [email protected] Roy R Fennimore Jr Ruchi Sahgal Ruchi Sahgal Principal Engineer Sr. QA, Analytical Sr. QA, Analytical Johnson & Johnson Astex Pharmaceuticals Astex Pharmaceuticals Raritan, NJ, United States Pleasanton, CA, United States Pleasanton, CA, United States [email protected] [email protected] [email protected] ruhul amin russbelt aliaga Russell Fortney Sr.QA Manager Technical director Team Leader Ad-din pharma Ltd Genzyme FDA Jessore, Non-US, Bangladesh Lima, Non-US, Peru Silver Spring, MD, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Ruth Aquino Ryan McCarthy S BALAJI QA Manager QA/QC Technician Deputy Manager QA Specialty Silicone Fabricators, Inc. Xttrium Laboratories Caplin point Laboratories Limited Tustin, CA, United States Mount Prospect, IL, United States Chennai, Non-US, India [email protected] [email protected] [email protected]
Saadia Alam Sabrina Mon Sachinkumar Patel QC Analyst (Validation Coordinator) Biotechnologist Chemist pfizer pharmaceuticals Medistem Panama Inc. US FDA Karchi, Non-US, Pakistan Panama, Non-US, Panama White oak, MD, United States [email protected] [email protected] [email protected]
Sai Patkar Sai Patkar Sailaja Chirravuri Research Assistant Graduate Research Assistant Regulatory Affairs Officer Bionanotechnology Laboratory Drexel University Mylan Philadelphia, PA, United States Philadelphia, PA, United States Bangalore, Non-US, India [email protected] [email protected] [email protected]
Sailaja Machiraju Sally Berry Sam Venugopal Research Associate Chief Medical Officer Partner ParagonBioteck Tris Pharma PwC Portland, OR, United States Monmouth Junction, NJ, United States San Jose, CA, United States [email protected] [email protected] [email protected]
Samantha Bouldin Samantha Kaltenbach Samia Nasr Director of Quality Control Quality Assurance Specialist Pharmacologist Advanced Breath Diagnostics ISTO Technologies, Inc. FDA Brentwood, TN, United States St. Louis, MO, United States Silver Spring, MD, United States [email protected] [email protected] [email protected]
Sampath Ayyappa sandeep uppaluri Sandra Garrido Quality Assurance Sr. QA Compliance Specialist President Appcure labs Fresenius Kabi USA TopFire, LLC Hyderabad, Non-US, India schaumburg, IL, United States Plano, TX, United States [email protected] [email protected] [email protected]
Sanjay Thorat sanjivani kulkarni sankalp sontakke Sr. Executive sr. Manager Internal audit Genpact-Pharmalink JBChemicals and pharmaceuticals Dr. Reddys laboratories ltd Mumbai, Non-US, India mumbai, Non-US, India hyderabad, Non-US, India [email protected] [email protected] [email protected]
Sanket Patel Sanobar Parkar Santhosh Manupati QA Director Drug safety Associate Human Biosciences AlphaMD Pvt Ltd Ascenders Consulting Services Gaitherburg, MD, United States Mumbai, Non-US, India Bangalore, KS, India [email protected] [email protected] [email protected]
SANTOSH NARLA Sara Ethier Sara Xiao Manager Regulatory Affairs Senior QA Manager Manager, Regulatory and Supply Chain Laurus Labs private limited Haemtech Biopharma Services Hisun Pharmaceuticals USA., Inc Hyderabad, Non-US, India Essex Junction, VT, United States Princeton, NJ, United States [email protected] [email protected] [email protected]
Sarah Kennedy Sarah Serrano SATISH CHAVA Document Control Assoicate I Corporate Director Quality Control Manager Nostrum Labs PL Developments Dr.Reddy's Laboratories Ltd Kansas City, MO, United States Miami, FL, United States Hyderabad, Non-US, India [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Savitha Rani Scott Murrin season Sun Assistant Manager - Regulatory Affairs Vice President of Quality Regulatory Department Orchid Healthcare Capstone Nutrition Yiling Pharmaceutical, Inc. Chennai, Non-US, India Ogden, UT, United States Vegas, NV, United States [email protected] [email protected] [email protected]
SEEMA GEETHA GOPAL Seema Joshi Sena Dissmeyer Supervisor Quality Assurance Manager Sr. QA Associate Apotex Inc Sun Pharma Pharmaceutics International, Inc. Richmond Hill, Non-US, Canada Gurgaon, Non-US, India Hunt Valley, MD, United States [email protected] [email protected] [email protected]
Seok Seo Seoung Yong Lee sereta muse Sr. QA Manager Counselor CONSULTANT Paramount Cosmetics Embassy of Republic of Korea QMASC(SC), INC. Clifton, NJ, United States Washington DC, DC, United States IRMO, SC, United States [email protected] [email protected] [email protected]
Seth Kreger Shahper Rahman Shalender Pratap Singh Product Development Manager Regulatory Manager Quality management system Cook MyoSite Reckitt Benckiser Alkem laboratories Limited Pittsburgh, PA, United States Parsippany, NJ, United States Badii, Non-US, India [email protected] [email protected] [email protected]
Shane Bailey Shanmuka Harish Chalamuri Sharad Kholambe Regulatory Affairs QA Specialist II Executive Virtus Pharmaceuticals Nostrum Laboratories Sun Pharmaceutical Industries Limited Tampa, FL, United States Kansas City, MO, United States Mumbai, Non-US, India [email protected] [email protected] [email protected]
Shariq Mehmood Sharon Maliar sharon Roberts Regularly Affairs Executive Executive consultant Pharmacist Pharmevo private limited PQE ECI Pharmaceuticals Karachi, Non-US, Pakistan Tel Aviv, Non-US, Israel Fort Lauderdale, FL, United States [email protected] [email protected] [email protected]
Shelley Mendenhall shelly fehr Shelly Shirkey Senior Director, Regulatory and QA IND/IDE Director Supervisor, Regulatory Affairs Inotek Pharmaceuticals Corporation UPenn Boehringer Ingelheim Chemicals,Inc. Lexington, MA, United States philadelphia, PA, United States Richmond, VA, United States [email protected] [email protected] [email protected] sheree mcgill sherry elchin Shi Qijun Manager- QA, ESH, Regulatory director of operations project manager PHT International, Inc. osiris therapeutics, inc chnmed Charlotte, NC, United States collumbia, MD, United States Beijing, Non-US, China [email protected] [email protected] [email protected]
Shirish Shah shirley shi Shuli Cui CSO, Development and Regulatory Executive VP Regulatory Intern EZRA Pharma LLC eVenuspharma Cerulean Pharma Phoenix, AZ, United States Princeton, NJ, United States Boston, MA, United States [email protected] [email protected] [email protected] shweta singh Siba Bhattacharyya Sidharth Puri Executive Chemist Manufacturing iMEDGlobal solution Pvt.Ltd CDER/FDA Johnson & Johnson Bangalore, KS, India Silver Spring, MD, United States Baddi, Non-US, India [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Silsymar Inácio Silvane Guzzi sneha inamdar Quality Auditor project manager Associate Prati-Donaduzzi Prati Donaduzzi &Cia Ltda Apotex Toledo, Non-US, Brazil Toledo, Non-US, Brazil miami, FL, United States [email protected] [email protected] [email protected]
SNIGDHA BEZAWADA Socorro Mogul Sohyun Suk Regulatory Operations Manager Sr Director Regulatory Affairs Associate CCS Associates PAR PHARMACEUTICAL INC Celltrion Pharm San Jose, CA, United States Chestnut Ridge, NY, United States Ochang, Non-US, South Korea [email protected] [email protected] [email protected]
Sonia Haley Sophia Finckbone Sophy Abraham Regulatory Consultant Manufacturing Supervisor Head of Regulatory Affairs Halloran consulting group ISTO Technologies, Inc. Elite Laboratories Inc. Richmond, VA, United States Saint Louis, MO, United States Northvale, NJ, United States [email protected] [email protected] [email protected]
SOUSSAN SHAZAND Sri Polina sri krishna chaitanya jammalamadaka QUALITY ASSURANCE MANAGER Regulatory Affairs Specialist Senior Executive PHARMASCIENCE PuraCap Pharmaceutical LLC Caplin Point Laboratories Ltd MONTREAL, Non-US, Canada South Plainfield, NJ, United States Chennai, Non-US, India [email protected] [email protected] [email protected]
Srinivas Peruri srinivas Yandrapu Sriramam Rayasam Marketing Manager Manager DQA BS Mylan Laboratories Limited Dr.Reddys Labs Duke Pharmacy Hyderabad, Non-US, India Princeton, NJ, United States Durham, NC, United States [email protected] [email protected] [email protected]
SRIRAMAM RAYASAM srivalli bontha Stefan Geanta BS assistant manager QA Manager DUKE PHARMACY COMPOUNDING xellia pharmaceuticals Impopharma Inc. FACILITY bangalore, Non-US, India Concord, Non-US, Canada DURHAM, NC, United States [email protected] [email protected] [email protected] Stephan Chang Stephan Chang stephane charland Director PhD Suplier Certification mgr Daewoong America Inc. Daewoong America Inc. Pharmascience Rockville, MD, United States Rockville, MD, United States Montreal, Non-US, Canada [email protected] [email protected] [email protected]
Stephanie Petaway-HIckson Stephen Tucker Steve Miller Regulatory / Compliance Manager Manager of Product Development Dir. Quality and Regulatory Affiars Calibration Technologies Cutanea Life Sciences Air Liquide Healthcare America Morris Plains, NJ, United States Wayne, PA, United States Houston, TX, United States [email protected] [email protected] [email protected] steve griffith Steve Hong Steve Huang VP - Business Development CEO RAS formpipe BCWORLD PHARM NIH Red Bank, NJ, United States Seoul, Non-US, South Korea Rockville, MD, United States [email protected] [email protected] [email protected]
Steven Goldner Steven Thomas Subramanian Iyer Director Quality Assurance Senior counsel Vice President Klus Pharma GSK Mylan Laboratories Limited Monmouth Junction, NJ, United States Raleigh, NC, United States Hyderabad, Non-US, India [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Sudhakar Bandari Sue Gifaldi Sue Wang President Senior Manager, Compliance Manager, Technical Consultant Aurex Laboratories Janssen Pharmaceuticals ITRI East Windsor, NJ, United States Holley, NY, United States ROCKVILLE, MD, United States [email protected] [email protected] [email protected]
Suhas katare Sumeet Parwe sungil ko Regulatory Affairs RA RA manager RRPL Sunstar Americas, Inc. seegene Mumbai, Non-US, India Elgin, IL, United States seoul, Non-US, South Korea [email protected] [email protected] [email protected]
Sunil Dahiya SUNIL KUMAR Suresh Anaganti Regulatory Scientist Asst Manager cGMP auditor Kinapse Life Sciences Sentiss Pharma private ltd Amneal Pharmaceuticals Gurgaon, Non-US, India GURGAON, Non-US, India New york, NY, United States [email protected] [email protected] [email protected]
Suresh Kumar Chennaparapu suresh kumar periyasamy suresh vujjini Sr.Manager-Regulatory affairs Microbiologist Sr Manager Raks pharma Pvt. Ltd caplin point laboratories ltd kashiv pharma visakhapatnam, Non-US, India chennai, TN, India Bridgewater, NJ, United States [email protected] [email protected] [email protected] surya patra susan zavala susan fasso Research Analyst EVALUATOR (DRUG REGISTRATION TEAM) CEO Phillip Capital India pvt Ltd DIGEMID Global Pharma GxP consulting Mumbai, Non-US, India LIMA, Non-US, Peru cherry Hill, NJ, United States [email protected] [email protected] [email protected]
Susan Horth Susan Ocon Susan Todd QA Manager Quality Control Senior Manager, Regulatory Affairs Endo Pharmaceutical Genentech-Roche West-Ward Pharmaceutical Corp Rye, NY, United States Vacaville, CA, United States Eatontown, NJ, United States [email protected] [email protected] [email protected]
Suzana Marusic Swathi Etikala syed saleem President RA Executive Chief Compliance Officer Hooke Laboratories, Inc. Sarvotham Care Apothecary health Lawrence, MA, United States Secunderabad, Non-US, India grand prairie, TX, United States [email protected] [email protected] [email protected]
Tab Dobbins Tae-Hyun Park Talpaneni Joseph Sunder Raj QC Senior Supervisor RA staff Group Analytical Manager Guthy-Renker Celltrion Pharm Dexa Medica Arden, NC, United States Cheong-Ju, Non-US, South Korea Jakarta, Non-US, Indonesia [email protected] [email protected] [email protected]
Tamara Clark Tamra Sami Tania Galcik Branch Chief Editor-in-Chief, Quality & Enforcement RA Specialist FDA FDAnews DynPort Vaccine Company Silver Spring, MD, United States Falls Church, VA, United States Frederick, MD, United States [email protected] [email protected] [email protected]
Tania Galcik Tania Martinez TANIA OVIEDO RA Specialist Regulatory Director Inspector - Specialist DynPort Vaccine Company Demos Global Group, Inc Dirección General de Medicamentos, Frederick, MD, United States Miami, FL, United States Insumos y Drogas [email protected] [email protected] Lima, Non-US, Peru [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Tara Nath Tara Norouzi tatiana short Quality Assurence QA auditor Caplin point labs ltd., NIH prati-donaduzzi Chennai, TN, India Bethesda, MD, United States toledo, Non-US, Brazil [email protected] [email protected] [email protected]
Teresa Bales Teresa Hernandez Teresa Tung Compliance Specialist Supervisor President Focus CVS Bayer Alpha Pharma Services LLC Knoxville, TN, United States Orizaba, Non-US, Mexico Lake Success, NY, United States [email protected] [email protected] [email protected]
Terrie Foster Tetyana Denyssevych Tetyana Dusaniwskyj Quality Assurance Document Control quality management officer Regulatory Affairs Project Manager Hewlett Packard BC Cancer Agency Osiris Therapeutics Inc. Des Moines, IA, United States vancouver, Non-US, Canada Columbia, MD, United States [email protected] [email protected] [email protected]
Thanhhoa Nguyen Thomas Berkheimer Thomas Busmann Scientist Quality Assurance Manager Manager, Process Engineering Amgen Barton Solvents, Inc. Focus Compliance and Validation Services Thousand Oaks, CA, United States Des Moines, IA, United States Knoxville, TN, United States [email protected] [email protected] [email protected]
Thomas Ingallinera Threshold Andersen thrilok p VP Senior Process Chemist Jr. Executive Pii Threshold Pharmaceuticals Caplin Point Laboratories Limited Hunt Valley, MD, United States South San Francisco, CA, United States Chennai, Non-US, India [email protected] [email protected] [email protected]
Thuy Nguyen Ti Wang Tim Ames Consumer Safety Officer Regulatroy Affairs Manager VP, Global Strategic Regulatory Affairs FDA Jiangsu Hansoh Mylan, Inc. Silver Spring, MD, United States Lianyungang, Non-US, China Washington, DC, United States [email protected] [email protected] [email protected]
Tina G Qiu Tina Sanford Tina Tong Ophthalmic Executive Consultant/Principal QA Specialist Health Specialist Directional Healthcare Advisors LLC ImmunoScience, Inc. NIH Peabody, MA, United States Dublin, CA, United States Rockville, MD, United States [email protected] [email protected] [email protected]
TJ Higley TJ Jacobs Todd Lumbert VP Director, IT Global Regulatory Compliance Site Head of Quality Powdersize Inc Celestica Inc. SPI Pharma Quakertown, PA, United States Toronto, Non-US, Canada Grand Haven, MI, United States [email protected] [email protected] [email protected]
Todd Sunstrom Tom Bolton Tom Huang Director QA Associate Director Regulatory Affairs CMC Manager ARx Nektar Therapeutics Klus Pharma Inc Glen Rock, PA, United States Huntsville, AL, United States Monmouth Junction, NJ, United States [email protected] [email protected] [email protected]
Tomaso Dameno Tonika Waugh Tooba Murshedkar Pharma GMDP Compliance Director Quality Assurance Associate Associate Director, Regulatory Affairs PQE Suisse ImmunoScience Sanaria Inc. Locarno, Non-US, Switzerland Pleasanton, CA, United States Rockville, MD, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Towana Elmore Travis Bemiss TRVV Subramanyam Quality Assurance Manager Nuclear Pharmasist Assistant Manager Convenience Valet Precision Nuclear Rakspharma Pvt. Ltd. Melrose Park, IL, United States Gey, TN, United States Visakhapatnam, Non-US, India [email protected] [email protected] [email protected]
TRVV Subramanyam Uday Kompella Udayaraj Kadri Assistant Manager-Regulatory Affairs CSO Head - Quality Assurance Raks Pharma Pvt. Ltd. Ocugen, Inc. Caplin Point Laboratories Ltd. Visakhapatnam, Non-US, India Aurora, CO, United States Chennai, Non-US, India [email protected] [email protected] [email protected] uri shpolansky Utkarsh Jaiswal Valeri Sewald CTO Assistant Manager Quality Assurance Client Relations physiological models Dr Reddy's Lab Coda Corp USA pardes hanna carcur, Non-US, Israel Hyderabad, Non-US, India Westfield, NJ, United States [email protected] [email protected] [email protected]
Valerie Ahmuty Vamshidhar Pillarishetty Veeraswamy Cherukuri Sr. Director, Regulatory Affairs RA Project Manager Manager-QA TherapeuticsMD Amneal Pharmaceuticals Lupin Ltd., Boca Raton, FL, United States Piscataway, NJ, United States Mumbai, Non-US, India [email protected] [email protected] [email protected]
VEERENDRA NANJWADE Venkat Ramana Krishna Chunduru VENKAT REDDY SUNKARA RESERACH EXECUTIVE Dy.Manager-QA Manager - Regulatory Affairs UNICHEM LABS Raks Pharma Aesica Pharmaceuticals Ltd Panjim, GA, India Visakapatnam, AL, India Cramlington, Non-US, United Kingdom [email protected] [email protected] [email protected] venkata varanasi venkatesh alla Venkatreddy Kumbam Regulatory Associate Sr. Associate Senior scientist riconpharma LLC Mylan Laboratories Limited ScieGen pharmaceuticals Inc Denville, NJ, United States Bangalore, Non-US, India Hauppauge, NY, United States [email protected] [email protected] [email protected]
Veronique St-Hilaire VIBHAKAR SHAH Victor Paulus Quality Projects Specialist Consumer Safety Officer Head, Regulatory Affairs Galderma USFDA Advanced Accelerator Applications USA Baie D'Urfé, Non-US, Canada Silver Spring, MD, United States New York, NY, United States [email protected] [email protected] [email protected]
Victoria Scott vijay kanani Vijayakumar Balasubramanian Associate Director Quality and Regulatory Regulatory Affairs - Executive Senior Manager Hemispherx Biopharma, Inc. Zydus cadila Harman Finochem Limited New Brunswick, NJ, United States Vadodara, Non-US, India Aurangabad, Non-US, India [email protected] [email protected] [email protected]
Vijayanand Chakrapani Vilas Malge Vilma Naupari General Manager Assistant Grade I Regulatory Affairs Evaluator WOCKHARDT LIMITED Sun Pharmaceutical Industries Limited DIGEMID Aurangabad, Non-US, India Vadodara, Non-US, India Lima, Non-US, Peru [email protected] [email protected] [email protected]
Vinay Bhatt Vinayak Pawar Vincent Li VP, Quality and R.A. Senior Review Microbiologist Chemist Leading Pharma,LLC Food & Drug Administration FDA Fairfield, NJ, United States Silver Spring, MD, United States Silver Spring, VA, United States [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Vini Patel Vinicius Beal Boufleur Vinod Mandowara RA Associate Analyst Manager-Business Development Bio-Pharm Inc. Prati Donaduzzi Sentiss pharma Levittown, PA, United States Toledo, Non-US, Brazil Gurgaon, Non-US, India [email protected] [email protected] [email protected] .br Vipin Vasanthakumar virendra khanapure Vishal Oza Manager - Regulatory Affairs Project Managment Regulatory Affairs Orchid Healthcare APC Pharmaceuticals and Chemicals Sun Pharmaceutical Industries Limited Chennai, Non-US, India Mumbai, Non-US, India Vadodara, Non-US, India [email protected] [email protected] [email protected] vishal patel Vishal Singh Viswesh Achanta Sr. Regulatory Affairs Assisstant General Manager Executive Teva Pharmaceuticals Inventia Healthcare Private Limited Daewoong Pharmaceutical Co Ltd Horsham, PA, United States Mumbai, MA, India Hyderabad, Non-US, India [email protected] [email protected] [email protected]
Vivian An Wai Yu Walter Jump RA Regulatory Affairs Supervisor President CSPC Pharmaceutical (Shijiazhuang)Co.,Ltd Carlsbad Technology, Inc. Cornerstone Regulatory LLC Shijiazhuang, Non-US, China Carlsbad, CA, United States Langhorne, PA, United States [email protected] [email protected] [email protected]
Wanda Hernandez Warren Crumplin Wei Zhang Project Manager Regulatory Affairs Chemist Vice President, QA/QC TherapeuticsMD Fine Chemicals Corporation Youngtech Pharmaceuticals, Inc. Boca Raton, FL, United States Cape Town, Non-US, South Africa Cranbury, NJ, United States [email protected] [email protected] [email protected]
Weifeng Ji weiwei hua weiwei hua Associate Director PM PM Relypsa, Inc HPC HPC Redwood city, CA, United States Bethsda, MD, United States Edison, NJ, United States [email protected] [email protected] [email protected]
Wendy Galbraith Wendy Linthicum Wendy Sanhai Pharmacist Product Compliance Scientist Senior managing Scientist University of Oklahoma USAMMDA Exponent Inc Oklahoma City, OK, United States Frederick, MD, United States Alexandria, VA, United States [email protected] [email protected] [email protected] wendy tan wendy whitfield Whitney Dollins Microbiologist Regulatory / Compliance Officer Quality Specialist FDA Piramal Healthcare UK Limited Apothecares Rockville, MD, United States Morpeth, Non-US, United Kingdom Decatur, AL, United States [email protected] [email protected] [email protected]
Whitney Dollins wilfredo Pimentel Del Valle Willaine Costa Quality Assurance Specialist pharmaceutical chemist Researcher Apothecares/ Southern Compounding E.B. Pareja Lecaros S.A Prati,Donaduzzi e Cia Ltda Decatur, AL, United States Lima, ME, Peru Toledo, Non-US, Brazil [email protected] [email protected] [email protected]
William Kwok William Tubbs William Turok Associate Director, RA Director Regulatory Affairs and Quality President and General Counsel BD Rx. Inc Assurance Corporate Pharma, Ltd. Franklin Lakes, NJ, United States Promedior Jersey City, NJ, United States [email protected] Lexington, MA, United States [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information William Turok William Washington Willian Tapia Tapia Ramírez President and General Counsel Director QA Consultor de Catalogación Corporate Pharma Rhodes Pharmaceuticals DIGEMID (Dirección General de Jersey City, NJ, United States Coventry, RI, United States medicamentos Insumos y Drogas) - Perú [email protected] [email protected] Lima, Non-US, Peru [email protected] wu can Xia Yang xian wu regulatory affairs assistant Regulatory affairs specialist CSPC Zhongnuo Pharmaceutical Jiangsu Hansoh Pharmaceutical Co., Ltd. Jiangsu Hansoh (Shijiazhuang) Co., Ltd. princeton, NJ, China Lianyungang, Non-US, China shijiazhuang, Non-US, China [email protected] [email protected] [email protected] Xiaohong Zhang xiaoli ma Xiong Lu regulatory affair QA Registration manager eastonpharma Furen Hetero Onco therapeutics Ltd. chnmed chengdu, Non-US, China Zhengzhou, Non-US, China Beijing, Non-US, China [email protected] [email protected] [email protected]
Xiumei Ruan xuan zhang Y Wang Chemist regulatory specialist Director FDA Daewoong Purdue Silver Spring, MD, United States Beijing, Non-US, China Stamford, CT, United States [email protected] [email protected] [email protected] yahya el-kattan Yanhong Qi Yanira Gonzalez-Berrios VP CMC QC Manager Chemist BioCryst Pharmaceuticals CSPC Zhongnuo Pharmaceutical FDA Birmingham, AL, United States (Shijiazhuang) Co., Ltd. Silver Spring, MD, United States [email protected] Shijiazhuang, Non-US, China [email protected] [email protected] Yanira Gonzalez-Berrios Yaolin Wang Yarery Smith Chemist Regulatory Specialist Microbiologist FDA Hengrui Pharm FDA Silver Spring, MD, United States Shanghai, Non-US, China Silver Spring, MD, United States [email protected] [email protected] [email protected]
Yaseen Momin Yasuyuki Shimoura Ye Zhang Manager Regulatory Affairs QA specifalist Reviewer Genpharma Sysmex America Inc. FDA El Jadida, Non-US, Morocco Lincolnshire, IL, United States Silver Spring, MD, United States [email protected] [email protected] [email protected]
Yen Nguyen Yesmil Pena Yinka Green Sr RA Associate Consultant Consultant Sandoz Consultant Independent princeton, NJ, United States Woodbridge, Non-US, Canada Waltham, MA, United States [email protected] [email protected] [email protected]
Yolma Gonzalez Yonghong Yang Yongli Lin Staff Scientist Manager Regulator affairs manager SHL pharma Kashiv Pharma LLC Zhejinag Starry Pharmaceutical Co., Ltd. Deerfield Beach., FL, United States Bridgewater, NJ, United States Xianju, Non-US, China [email protected] [email protected] [email protected]
York Tomita YSABEL SONIA GUTIERREZ AURES YU XUE Science Adv PHARMACYST International certification FDA DIGEMID LUYE PHARMA Silver Spring, MD, United States LIMA, Non-US, Peru YANTAI, Non-US, China [email protected] [email protected] [email protected]
FDA – CDER – RedI: Focus on CGMP & FDA Inspections – Participant List These participants granted permission to share their contact information Zahid Muhammad Zhengpin Guan zhi chen Director Quality Assurance Quality Director Manager of regulatory affairs Pii Sichuan Qingmu Pharmaceutical Co., Ltd. Prinston Pharmaceutical Inc. Towson, PA, United States Chengdu, Non-US, China cranbury, NJ, United States [email protected] [email protected] [email protected]
Zichun Liu Zulfiqar Choudary Zuo Sophia International registration QA/RA Manager QA manager Waterstone(Hubei) Pharmaceutical Co.Ltd JABIL Circuits Inc Zjpharma.Inc. Wu han, Non-US, China Auburn Hill, MI, United States Shijiazhuang, Non-US, China [email protected] [email protected] [email protected]
青 郎 RA CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd Shijiazhuang, Non-US, China [email protected]