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