Medical Device Packaging: Innovations in Design and Testing

Home , Packaging engineering

2nd Annual MEDICAL DEVICE PACKAGING: INNOVATIONS IN DESIGN AND TESTING APRIL 30 - MAY 1, 2015 | BETHESDA, MD Optimizing Medical Device Package Design through Incorporating End User Feedback, Leveraging Legacy Testing Studies & Identifying Innovative Materials, while Maintaining Validation & Verification Standards through Examining Test Methods to Satisfy Global Regulatory Expectations

DISTINGUISHED PRESENTERS INCLUDE: Abhishek Gautam Daniel Burgess Dhuanne Dodrill Manager, Packaging Engineering Principal Packaging Engineer Chairman CONMED CORPORATION BOSTON SCIENTIFIC ASTM INTERNATIONAL COMMITTEE F02 Catherine Olson, MSN, RN Charlie Rivera Director, Institute for Quality, Safety and Corporate Packaging Operations Manager A.J. Gruber Injury Prevention CONMED CORPORATION Executive Vice President EMERGENCY NURSES ASSOCIATION ISTA Nora Crivello Philip Desjardins Vice President Dawn Fowler Counsel WESTPAK INC. Senior Manager, Labeling & ARNOLD & PORTER LLC Documentation Shirley Gibson ENDOLOGIX Michael H. Scholla, Ph.D. Associate Vice President of Nursing Global Director, Regulatory and VCU HEALTH SYSTEM Tomas Pla Standard Sr. Development Packaging Engineer DUPONT PACKAGING Paul Marshall EXACTECH Manager, Global Packaging Art Castronovo Technologies Jonathan Bull Dir. of Labeling and Packaging SMITH & NEPHEW Director Gas and Heat Sterilization Engineering JOHNSON & JOHNSON SMITHS MEDICAL Santosh Madival Sr. Packaging Engineer Rod Patch Rients Van Werven EDWARDS LIFESCIENCES Senior Director, Execution Excellence Manager GSG Package Development COE Packaging and Product Labeling Ron Valerio JOHNSON & JOHNSON ETHICON ENDO-SURGERY Sr. Manager Medical UFP TECHNOLOGIES Darian Flewellen Dawn Hamblett Development Engineer, Packaging OR Clinical Product Coordinator Maimunatu Mansaray EXACTECH GEORGE WASHINGTON Operating Room Nurse UNIVERSITY HOSPITAL HOWARD UNIVERSITY HOSPITAL Alison Tyler Director of Technology Katie Tran Ewald Heersema BEACON CONVERTERS, INC. Lab Supervisor Technical Business Manager WESTPAK ZOTEFOAMS INC Chetan Patadiya Sr. Packaging Engineer Dr. Javier de la Fuente Changchun Liu, PHD EDWARDS LIFESCIENCES Assistant Professor Research Assistant Professor CALIFORNIA POLYTECHNIC STATE UNIVERSITY OF PENNSYLVANIA Dan Penny UNIVERSITY Director of Packaging Engineering CARDINAL HEALTH

CONFERENCE SPONSORS: PREMIER SPONSORS:

500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com MEDICAL DEVICE PACKAGING: INNOVATIONS IN DESIGN & TESTING APRIL 30 - MAY 1, 2015 | BETHESDA, MD

PROGRAM OVERVIEW: PREVIOUS ATTENDEES INCLUDE: Reducing costs while maintaining innovation in packaging continues to be of top Director, Engineering, ACUMED priority throughout the medical device industry as the healthcare landscape moves Product Manager, ACUMED towards a customer-centric business model engaging the end-user throughout the Sr. Engineer to Project Engineer, ALLERGAN product lifecycle. Engineers are tasked with the responsibility of creating innovative Senior Packaging Engineer, AMERICAN MEDICAL SYSTEMS packaging that will protect lifesaving medical devices throughout the supply chain Senior Quality Engineer, APOLLO ENDOSURGERY and lifecycle of the product while also reducing cost and remaining compliant with Manager, Packaging Engineering, ARTHROCARE CORP regulatory guidelines. This year’s conferencewill build upon the concerns of last TEN-E Packaging Services (D10 Chair), ASTM COMMITTEE year’s event by addressing the current concerns of packaging engineers through case Chairperson, ASTM COMMITTEE studies, panel discussions and end user small group feedback. Director EHS and Sustainability, BAXTER Attendees of this year’s program will be provided with the unparalleled opportunity to R&D Manager/ HPRC committee Member, BD discuss testing validation and verification challenges through case studies surround- Package Engineering Manager, BD DIAGNOSTICS ing good manufacturing practices including identifying where legacy studies can be Packaging Engineer, BD DIAGNOSTICS leveraged or testing is needed. Testing presentations will also address sterilization, Staff Engineer, Packaging, BD MEDICAL shelf life, sample size and unique testing methods available. End user concerns includ- Team Leader - Graphics and Packaging, BD MEDICAL ing sterility and ease-of-use will be addressed through small group discussions where Senior Manager, BECKMAN COULTER nurses will examining and provide feedback on packages provided by attendees. Manager, Packaging Engineering, BOSTON SCIENTIFIC Principal Packaging Engineer, BOSTON SCIENTIFIC KEY CONFERENCE SPEAKERS INCLUDE: Corporate Packaging Operations Manager, CONMED Manager of Packaging Engineering, CONMED-LINVATEC Dr. Javier de la Fuente Packaging Engineering Manager, COVIDIEN Assistant Professor Sr. Design Engineer- Packaging, COVIDIEN CALIFORNIA POLYTECHNIC Sr. Sterile Packaging Engineer, DEPUY SYNTHES STATE UNIVERSITY Manufacturing Eng. Packaging Manager, DSM BIOMEDICAL Senior Packaging Manager, DSM BIOMEDICAL EDWARDS LIFESCIENCES Dr. de la Fuente serves as Assistant Professor of Packaging Engineer, ENDO THERAPEUTICS Industrial and Packaging Technology in the Orfalea Manufacturing Engineer Manager, College of Business at the California Polytechnic Sr. Manager, Document Control and Labeling, ENDOLOGIX State University. He teaches courses in design think- Director of Filling & Finishing, FUJIREBIO DIAGNOSTICS ing, product design and development, computer Supervisor, Operating Room, GEORGE WASHINGTON HOSPITAL aided design, and packaging.r. de la Fuente’s back- OR Product Coordinator, GEORGE WASHINGTON HOSPITAL ground includes industrial and graphic design, packaging, and scientific research. Packaging Engineering Manager, HEARTWARE, INC. His research interest lies in the area of user-centered design, universal/inclusive Packaging Manager, HOLLISTER design, communication of functionality (affordances), and healthcare packaging. Manager, Packaging, INTEGRA LIFESCIENCES He has more than 30 publications including books chapters, peer-reviewed articles, Manager of Packaging, INTEGRA LIFESCIENCES refereed conferences, and trade-press articles. He has co-authored the “Packaging Sr. Packaging Engineer, INTUITIVE SURGICAL Design and Development” and the “Medical Device Packaging” chapters in the last edi- VP Sterile Process Technology, JOHNSON & JOHNSON tion of the Wiley Encyclopedia of Packaging Technology. One of his papers won the pres- K2M tigious Best Paper Award at the Cambridge Workshop on Universal Access and Assis- Project Engineer, tive Technology organized by the Engineering Department at University of Cambridge. Packaging Engineer 1, KIMBERLY CLARK HEALTHCARE Vice President of Technology, LANSMONT A.J. Gruber Senior Packaging Engineer, LIFECELL CORP Executive Vice President Packaging Engineer, LIFECELL CORP ISTA Principal Quality Engineer lead statistician, MEDTRONIC Associate Packaging Engineer, MEDTRONIC Packaging Engineer Manager, MEDTRONIC A.J Gruber is the Executive Vice President for the Associate Professor, HUMAN MEDICINE International Safe Transit Association. He is respon- VP of sterilization Operations, NOVOSCI sible for both internal and external relationships PACKWISE CONSULTING which include interacting and communicating with Principal Packaging Engineer, staff across functional areas, motivating a team Marketing Manager, PETOSKEY PLASTICS commitment to the ISTA’s vision and mission, and Contract Sterilization Manager, REVOX STERILIZATION representing the Association through public speak- Eastern Regional Manager, REVOX STERILIZATION ing and communications with members and other industry partners. Also responsible Product Manager, REVOX STERILIZATION for overseeing the processes through which ISTA maintains contact with members or Packaging Engineer, RTI SURGICAL other stakeholders ensuring that the relationships remain conducive to the success Project Manager, Marketing, SHL GROUP of the Association. Before joining ISTA, A.J. held roles within UPS as an Engineering Packaging Development Engineer, SMITH & NEPHEW Solutions Specialist and Supervisor of Dangerous Goods. A.J. currently also resides Dir., Global Packaging Development, SMITH & NEPHEW as the chair of IoPP Transport Packaging Committee and is on the board of the Mich- Sr. Packaging Engineer, SMITH & NEPHEW ORTHOPEDICS igan State University Packaging Alumni Association. Lifecycle Packaging Engineer, STRYKER Associate Project Engineer, STRYKER RAPS CERTIFICATION: Packaging Engineering Manager, STRYKER This conference has been pre-approved by the Regulato- Packaging Engineer, STRYKER Principal Packaging Engineer, STRYKER ry Affairs Professionals Society (RAPS) as eligible for up Senior Packaging Engineer, STRYKER to 12 credits towards a participant’s RAC recertification Senior Packaging Engineer, STRYKER upon full completion. Director, Packaging Design, STRYKER

500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com MEDICAL DEVICE PACKAGING: INNOVATIONS IN DESIGN & TESTING DAY ONE | THURSDAY, APRIL 30

7:00 REGISTRATION & MORNING COFFEE 12:15 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS 7:50 CHAIRPERSON’S OPENING REMARKS 1:30 PANEL DISCUSSION: CHOOSING COST EFFECTIVE AND INNOVATIVE PACKAGING MATERIAL 8:00 BALANCING REGULATORY COMPLIANCE AND INNOVATIVE Medical device manufacturers need to develop packaging that not only pro- PACKAGING DESIGN tects and sterilizes a product but also satisfies end-user desires to maintain To remain competitive within the medical device industry, engineers focus competitiveness within a market. Packaging engineers must carefully ana- greatly on developing innovative designs for product packaging to ensure lyze the properties of various foams, films and plastics to select the best ma- sterilization and safeguard a medical device, augment the value of a product terial combinations for a product. Several factors including budget, a medi- through dual-use packaging and minimize carbon footprint while maximizing cal device’s components, shape and size along with expected handling and cost savings through decreased material usage. While innovation is at the use are crucial factors when determining appropriate packaging materials. center of all packaging endeavours, packaging teams must also remain com- This panel discussion will examine various packaging materials that have pliant with regulatory guidelines set forth by the FDA and international regu- been validated and approved to highlight new material options and combi- latory bodies. Without hindering progress within the medical device industry, nations available for engineers. packaging executives must find a happy medium in identifying and creating • Examining name brand vs. generic packaging materials innovative packaging while also adhering to strict regulations. • Identifying innovative packaging material suppliers • Challenges of developing innovative packaging designs • Lessons learned through combination trial and error • Understanding regulatory expectations US/OUS Ewald Heersema, Technical Business Manager, ZOTEFOAMS INC • Design implications on regulatory submissions Ron Valerio, UFP TECHNOLOGIES Paul Marshall, SMITH & NEPHEW Senior Manager Medical, Mgr., Global Packaging Technologies, Dan Penny, Director of Packaging Engineering, CARDINAL HEALTH 8:45 HOW WILL UDI IMPACT YOU IN 2015? Rod Patch, Sr. Dir., GSG Package Development COE, JOHNSON & JOHNSON This UDI session will take look back on the September 2014 deadline for class III medical devices, looking to understand how effective implementa- 2:15 OVERCOMING CHALLENGES IN DESIGNING AND UPDATING A tion has been and will provide lessons learned for the future deadlines. PACKAGING PROTOTYPE • How class II device companies can execute successful UDI implementation Evaluating the performance of various packaging prototype designs allows • Lessons learned from implementation – where are the gaps? engineers the ability to identify flaws or potential risks within designs prior to • The US implementation was just the beginning - international UDI production. Outlining the packaging design inputs like device classification, guidance, where do we go next? shelf-life expectations, packaging materials and manufacturing processes • Discussion around UDI implementation - real case studies will streamline design decisions ultimately leading to successful validation Dawn Fowler, ENDOLOGIX of a package. Examining best practices for developing an accurate prototype Senior Manager, Labeling & Documentation, while also addressing changes after a prototype has been designed ensures 9:15 COFFEE & NETWORKING BREAK successful packaging development is achieved. • Working with prototyping firms and material manufacturers 9:45 PANEL DISCUSSION: BEST PRACTICES FOR IMPLEMENTING • Managing effects of device design changes in packaging prototype UDI REQUIREMENTS • Collaborating with marketing on prototype design input With phase one of the UDI program in place, medical device companies are • Reviewing input and modifying packaging designs either already implementing UDI requirements for class III device and or pre- Abhishek Gautam, Mgr., Packaging Engineering, CONMED CORPORATION paring for the next round of implantable, life-supporting and life-sustaining devices labeling and packaging requirements. How this new requirement is 3:00 COFFEE & NETWORKING BREAK affecting packaging professionals as well as how the FDA is dealing with noncompliance is of high concern within the industry. Through this panel dis- 3:15 DRAFTING A ROBUST PACKAGING VALIDATION PLAN cussion industry experts will share firsthand experiences on the challenges Validation of the packaging process is an important step to ensure that the specifically facing packaging professionals in regards to UDI implementation equipment used to form, seal and assemble a sterile barrier system is in as well as examine how the FDA is handling noncompliance. fact qualified. The first step in aligning an organization with ISO 11607-2 is drafting an effective validation plan which will outline the packaging pro- Dawn Fowler, Senior Manager, Labeling & Documentation, ENDOLOGIX cess, qualifications steps, sterilization procedures and intended materials Art Castronovo, Dir., Labeling & Packaging Engineering, SMITHS MEDICAL and equipment to be used. Utilizing this plan throughout the organization will Philip Desjardins, Counsel, ARNOLD & PORTER LLC reduce risk and variations used throughout the packaging process. 10:30 SMALL GROUP DISCUSSIONS: ANSWERING TO THE • Best practices for effectively developing a validation plan HEALTHCARE PROVIDER CONCERNS • Harmonizing validation processes throughout an organization • Identifying non-conformities to mitigate risk As the healthcare landscape navigates towards a patient-centric driven industry, it is more important than ever that medical device manufacturers Charlie Rivera, Corporate Packaging Operations Manager produce products that fit seamlessly into this model. Oftentimes the decid- CONMED CORPORATION ing factor for devices selected ends with the nurse or clinician choosing the 4:00 STRATEGICALLY EXECUTING A VALIDATION PLAN ACROSS AN most appropriate product for the patient. Ease-of-use, sterilization abilities ORGANIZATION and historical success rates are just a few examples of the elements cus- Drafting a validation plan early in the design process will set the stage for tomers evaluate in choosing a medical device. By inviting nurses and other downstream success allowing for collaboration between packaging engi- clinicians to lead small groups and analyze packaging from medical devices neers and team members to set clear parameters for potential design issues. provided by conference attendees, engineers will have the unique and valu- Identifying implementation strategies for IQ, OQ, PQ, peeling test and docu- able opportunity to receive first-hand feedback from healthcare providers. menting quality properties will produce a robust validation report resulting Dawn Hamblett, OR Clinical Product Coordinator in validation approval. Attendees will leave this session with tools and tech- GEORGE WASHINGTON UNIVERSITY HOSPITAL niques to improve and harmonize their packaging process validation plans. Maimunatu Mansaray, Operating Room Nurse • Obtaining accurate IQ, OQ and PQ documentation HOWARD UNIVERSITY HOSPITAL • Best practices for conducting the peeling test Shirley Gibson, Associate VP of Nursing, VCU HEALTH SYSTEM • Inspecting quality properties including: seal, tear and separation Tomas Pla, EXACTECH Catherine Olson, MSN, RN, Director, Institute for Quality, Safety and Injury Sr. Development Packaging Engineer, Darian Flewellen, EXACTECH Prevention, EMERGENCY NURSES ASSOCIATION Development Engineer, Packaging, 4:45 COFFEE & NETWORKING BREAK 11:30 ADDING VALUE TO MEDICAL DEVICE PACKAGING WITHOUT INCREASING COSTS 5:00 STERILIZATION PROCESS AND MATERIALS: MAKING THE Utilizing packaging not only to protect and sterilize devices but also to provide RIGHT CHOICE end users with a positive experience will increase profits and create value in With an abundance of various sterilization options including steam, ETO, ra- the product. Packaging design, both structural and graphic, that is focused diation and E-Beam, it can be difficult for packaging engineers to correctly on user and stakeholders’ needs has the enormous potential of adding val- identify the best method for testing a particular package. Crucial factors that ue. However, designers often face challenging economical constraints while must be taken into account include the composition of materials used within trying to enhance packaging performance. In this puzzling scenario, it is criti- a package and identifying when changes should result in retesting. Attend- cal to understand how users interact with packaging and what are the design ees will delve below the surface in this presentation that examines proven features that might reduce or keep costs low while adding value. testing combinations of sterilization and material selections. • Understanding how people interact with medical device packaging. • Combining materials and sterilization methods for success • Analyzing how design can add value without increasing costs. • Understanding what types of changes require retesting • Individual design changes to improve usability and reduce user errors • Sterilization methods of the future reviewed Dr. Javier de la Fuente, Assistant Professor • Strategies for stability testing CALIFORNIA POLYTECHNIC STATE UNIVERSITY Jonathan Bull, Director Gas and Heat Sterilization, JOHNSON & JOHNSON 5:45 END OF DAY ONE CONFERENCE MEDICAL DEVICE PACKAGING: INNOVATIONS IN DESIGN & TESTING DAY TWO | FRIDAY, MAY 1

7:30 REGISTRATION AND MORNING COFFEE 12:45 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS 7:50 CHAIRPERSON’S OPENING REMARKS 1:45 OPTIMIZING PACKAGING & LABELING CONFIGURATIONS FOR THE INTERNATIONAL SUPPLY CHAIN 8:00 HCP FEEDBACK: A REVIEW OF SMALL GROUP DISCUSSIONS Shipping medical devices internationally requires specific knowledge of la- The conference chairperson will guide attendees through key insights shared beling requirements in order to obtain regulatory approval and market ac- by healthcare professionals during the small group discussions on the first cess. Utilizing this regulatory knowledge will give packaging engineers the day of the program. This 30-minute review will provide attendees with valu- ability to properly calibrate and configure medical device packaging in a cost able feedback provided by HCPs regarding preferences for materials and effective manner. This session will highlight specific international primary components of medical device packaging. and secondary packaging labeling expectations and examine best practices 8:30 STATUS UPDATE OF THE TYVEK® MEDICAL PACKAGING for reducing the risk of regulatory scrutiny. TRANSITION PROJECT Rients Van Werven, Execution Excellence Manager Packaging and Michael H. Scholla, Ph.D., Global Director, Regulatory and Standards Product labeling, ETHICON ENDO-SURGERY DUPONT MEDICAL AND PHARMACEUTICAL PACKAGING 2:15 PANEL DISCUSSION: VOICES OF THE SUPPLY CHAIN ON 9:15 IDENTIFYING PROCESS CHANGES AND WHEN REVALIDATION IS PACKAGING NECESSARY Maintaining complete control of the sterility of a product is achievable within Requirements for validation of ISO 11607-2 is fairly common knowledge but the confines of a manufacturing facility; however, once a product is shipped, one area sometimes lacking clarity is the process of understanding what it can be exposed to circumstances or conditions which may compromise the types of changes require revalidation. The process of revalidation can be a integrity of a medical device or its packaging. It is imperative that packaging timely and costly event, and therefore it is critical that packaging engineers engineers understand the complexities within the supply chain in order to can differentiate between self-evident changes that require revalidation ef- prepare packaging to withstand those elements. Collaborating with supply forts verses events that can leverage existing regulations for partial revalida- chain professionals to establish risk-based design features will ensure pack- tions or avoid revalidation entirely. Developing rationale to support revalida- aging maintains the sterility of the device throughout transit. tion plans and understanding packaging regulatory requirements in the US Rients Van Werven, Execution Excellence Manager Packaging and and abroad will ensure resources are streamlined throughout revalidation. Product labeling, ETHICON ENDO-SURGERY • Examining various change scenarios for revalidation Katie Tran, Lab Manager, WESTPAK • Building revalidation on previous documented validation • Understanding regulatory requirements for retesting in US and abroad 3:00 COFFEE & NETWORKING BREAK Chetan Patadiya, Sr. Packaging Engineer, EDWARDS LIFESCIENCES 3:15 CASE STUDY: UNDERSTANDING THE IMPORTANCE OF Santosh Madival, Sr. Packaging Engineer, EDWARDS LIFESCIENCES DISTRIBUTION TESTING Alison Tyler, Director of Technology, BEACON CONVERTERS, INC. Medical device packages undergo vigorous sterility, agenizing, integrity, design and qualification testing to ensure safety and efficacy of the product. 10:00 COFFEE & NETWORKING BREAK While much attention is placed upon the other aspects of package testing, 10:30 DESIGNING TEST METHOD PACKAGING VALIDATION SYSTEMS distribution standards ASTM D4169, ISTA 2 Series and ISTA 3 Series are A recent increase in scrutiny by the FDA regarding methods used to evaluate crucial to ensure defects are avoided and sterility is maintained. Examining medical device packaging during the development process is due in part potential challenges a package will face throughout the supply chain will to the fact that 47% of all sterility-related recalls were attributed to packag- ensure that distribution testing is a successful event. ing defects according to the medical device packaging handbook. Therefore • Reviewing ASTM D4169, ISTA 2 Series and ISTA 3 Series putting a robust packaging test plan in place is essential as it ensures that • Adapting testing criteria to shipping patterns the end user receives a sterile device and mitigates the risks of discovering • Accounting for environmental factors throughout transportation design failures late in the development process. By understanding the com- • Evaluating the outsourcing of distribution testing ponents that make up a robust test plan, attendees can begin designing A.J. Gruber, Executive Vice President, ISTA their own effective product development packaging test methodologies. 4:00 DESIGN, FABRICATION AND ASSEMBLING OF MICROFLUIDIC, Daniel Burgess, Principal Packaging Engineer, BOSTON SCIENTIFIC POINT OF CARE MEDICAL DEVICES 11:15 ASTM TESTING EXPECTATIONS AND UPDATES TO DYE Lab-on-a-chip (or microfluidic chip), which hosts a miniaturized fluidic net- PENETRATING TESTING work with pre-stored (lyophilized) reagents for processing and analysis of Evaluating the ability of packaging to withstand stressors such as climate, vi- clinical specimens (blood, saliva, urine), is an emerging, point-of-care (POC) bration, shock, humidity, temperature extremes, and altitude changes is argu- diagnostics, medical devices. These devices are often used in resource-lim- ably necessary to ensure medical devices remain safe and effective for use. ited settings which place stringent demands on device design and assem- Understanding ASTM testing standards and anticipating expectations prior bling to minimize contamination during operation in the field. Manufacturing to testing will ensure that packages are validated and comply with regulatory methods must be compatible with pre-loading dry-stored reagents (enzymes, guidelines. In addition, recent enhancements to the standard dye penetrat- dyes) during their assembly and packaging. ing testing of nonporous (ASTM F3039-13) packaging will be reviewed and • Microfluidic, POC device design, fabrication & formats including packaging will allow for user flexibility when performing packaging seal integrity testing. • Novel methods and packages of POC device for blood fractionation • ASTM testing preparation and onsite expectations (plasma separation) • Dye penetrating testing enhancements reviewed • Lyophilization, encapsulation and sealing of enzymes and reagents for • Testing standards pipeline: future methods examined POC molecular diagnostics devices. Dhuanne Dodrill, Chairman, ASTM INTERNATIONAL COMMITTEE F02 Changchun Liu, PhD, Research Asst. Prof., Dept. Mechanical Engineering & Applied Mechanics, UNIVERSITY OF PENNSYLVANIA 12:00 BEST PRACTICES FOR MITIGATING POTENTIAL PACKAGING PITFALLS 4:45 END OF DAY 2 & CONFERENCE CONCLUSION Medical device packaging engineers face many challenges throughout the packaging process from designing innovative packaging configurations with limited resources to validating that the materials and components can main- WHO SHOULD ATTEND: tain sterility throughout the supply chain. Discussing these challenges and solutions to other common roadblocks, packaging engineers will have the Executives that will find this program of greatest relevance are those cur- unique ability to incorporate risk management strategies and tactics into rently working to design and develop innovative and efficient packaging for the validation process. In this presentation, Westpak will share some of the medical device manufacturers. Job titles of those executives that will find packaging challenges observed to help avoid common package failures oth- this program to be most applicable to their job functions include: ers have encountered. Confidentiality will be maintained while learning how • Packaging to successfully streamline validation processes. • Global Packaging • Packaging Services Katie Tran, Lab Supervisor, WESTPAK • Packaging Engineer • Packaging R&D Nora Crivello, Vice President, WESTPAK • Strategic Packaging • Product Assembly & Packaging • Packaging Development • Packaging Sterilization MEDIA PARTNERS: