Combination Products Summit: Streamlining 21 CFR Part 4 Compliance


Dr. Mary C. Getz, Vice President, NSF Health Sciences-Medical Device Consulting
(Workshop Chairperson)

Mary C Getz, PhD is the Vice President of Quality Systems, Medical Devices Consulting for NSF Health Science. Prior to joining NSF, she had over 25 years of experience within both Pharmaceutical and Medical Device Industries. During her tenure in industry, Mary held various roles within Fortune 500 Companies in Quality, Compliance, and Regulatory Affairs organizations and had a proven track record of success as VP and SVP of Quality and Compliance. Mary has a PhD in Microbiology and Molecular Genetics from Rutgers, as well as a Black Belt Certification in Six Sigma, which she uses along with her considerable experience to help clients’ remediate and build strong Quality and Compliance programs.

John (Barr) Weiner, Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA

John (Barr) Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug law, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a BA from Princeton University and a JD with honors from the Columbia University School of Law.

Michelle Garrett, Operations Manager, NSF International Health Sciences, Medical Devices




Patti Gupta, President, Patti Gupta & Associates LLC

Patti Gupta has more than eight years of experience with corporate Quality Assurance/Compliance departments within Merck Manufacturing Division and Genentech Inc. She also worked for more than ten years experience at the FDA with seven years as an investigator and three years as a supervisory investigator. In addition, she has eight years of clinical microbiology experience; two years of research experience in interferon production and tissue culture techniques; and one year as a sales representative specializing in microbiological products.

Olivia Wong, Director, NSF Health Sciences, Medical Device Consulting

Olivia Wong has over 13 years of industry experience, including extensive expertise in developing quality/compliance strategies and solutions, as well as in project management. She possesses significant experience in managing cross-functional efforts and initiatives, including but not limited to: strategic planning; clinical trials; design control; risk management and mitigation; product/process scale-up; international and domestic regulatory submissions; GxP; CAPA/complaint handling; and auditing. Throughout her career, Ms. Wong has assisted global pharmaceutical and medical device companies in the development and maintenance of comprehensive, robust Quality Systems, with a considerable focus on Design Controls. In combination with her pre- and post-market regulatory and compliance expertise, she also possesses proven success in budget and resource management, mentoring and creative problem solving. Ms. Wong received her MBA from Swiss Business School (SBS) in Z├╝rich, Switzerland and holds a Bachelor of Science in Neurobiology, Physiology, and Behavior (NPB) from UC Davis.

Amit Khanolkar, Director, Combination Products & Emerging Technologies PQM, Johnson & Johnson Janssen Pharmaceuticals

Amit Khanolkar is currently Director, Combination Products & Emerging Technologies within the Combination Product Center of Excellence at Janssen Pharmaceutical Companies of Johnson & Johnson. In his current role, Amit is involved in providing leadership and oversight for development, commercialization and lifecycle management of Janssen Combination Product portfolio. Amit has a background in Medical Device and Combination Product development, having spent 12 years in R&D in the Medical Device & Diagnostics (MD&D) sector of Johnson & Johnson; where he held successive roles of increasing responsibilities in product & process development as well as commercialization of numerous medical devices. Amit has actively collaborated across operating companies/sectors of Johnson & Johnson and provided strategic leadership in evaluating product and technology concepts in drug device combinations and convergent technologies. Prior to Johnson & Johnson, Amit worked in materials and process development of high performance polymer materials for the pharmaceutical/medical device and semiconductor applications. Amit holds a Master of Science degree in Polymer Engineering from the University of Akron and an MBA from University of Florida. He is a certified Design Excellence Black Belt, Process Excellence Green Belt and also has a certification in Statistical Engineering.

Dr. Dvorah (Debby) Feder, Director, Analytical Chemistry Research & Technology, Abbott Vascular

Debby Feder is the Director and Head of Analytical Chemistry Research & Technology with Abbott Vascular, which includes Analytical Development, Bioanalytical Development, Material Characterization Lab, Molecular & Cell Biology, R&D and Commercial Stability, and Analytical Operations. Debby is also the technical strategy lead for the Absorb BVS program, and acts as primary liaison between Regulatory Affairs and technical teams on submission strategies. Debby created and integrated Laboratory Controls for Abbott Vascular, and serves as divisional owner of this key quality system. She is also the divisional CMC lead for drugs used in Abbott Vascular’s combination products or licensed to partners. Prior to joining Abbott in 2006, Debby was Director and Head of Analytical Development at Scios, Inc. (a J & J company). She also held positions at Millennium Pharmaceuticals and COR Therapeutics. Debby attended the Hebrew University of Jerusalem, Israel and received her Ph.D. in Biochemistry under Professor Alexander Levitzki. She did a postdoctoral fellowship at the University of California San Francisco (UCSF) in the laboratory of Professor J. Michael Bishop.

Jie Hu, Manager, Material Characterization Lab and Bioanalytical Services, Abbott Vascular

Jie Hu is Manager of the Materials Characterization and Bioanalytical Development Laboratories with Abbott Vascular. Jie has over 20 years experience in the pharmaceutical, biotechnology, and combination product industries. He is an established expert on chromatography, spectroscopy, as well as materials characterization techniques for qualitative and quantitative chemical analysis. Jie is responsibile for GLP and non-GLP PK testing to support Abbott Vascular combination products, and for materials characterization for all the R&D programs. In addition to providing product investigation and troubleshooting support, Jie is responsible for development, validation, transfer and implementation of test methods used in product design, process development and optimization, product assessment and GLP or GMP testing. Prior to joining Abbott in 2007, Jie held positions in the Advanced Spectroscopy & Materials Characterization group at J&J West Coast Pharm Center and in the Mass Spectrometry and Protein Chemistry group at Scios (a J&J company). Jie received his M.Sc. in Chemistry from San Francisco State University, and a B.Sc. in Material Science from Nanjing University of Technology, China.

John Karels, Principal, Project Solutions Consultants

As a Principal Consultant for the pharmaceutical, medical device and biotech industries, John has over twenty years of experience interpreting QSR/GMP requirements as well as quality concepts in order to design and implement effective Quality Systems. He also has significant expertise in validation concepts and techniques. Through the application of risk-based methodology during product and process assessments, John is able to strategically plan and execute against validation requirements. He is also experienced in FDA pre-market submissions and applications, quality system development and auditing, aseptic processing, sterilization, managing the commissioning and validation of foreign and domestic manufacturing facilities, and large-scale compliance project management. Utilizing his multi-faceted background, John is able to blend his knowledge and experience around quality concepts, regulations, validation principles, and manufacturing operations to deliver effective compliance solutions. John has a Bachelor of Science in Microbiology from the University of Illinois, and a Masters in Business Administration/Technology Management from the Illinois Institute of Technology.

Christy Skinner, Quality Assurance, W.L. Gore and Associates

Christy Skinner has 20 years of quality experience in the medical device industry, and in recent years the combination product industry. Christy is an enthusiastic learner, and is a goal oriented individual with a positive work ethic that obtains results. Christy is extremely knowledgeable and has practical experience regarding CAPA, Complaints, Design Control, Equipment/Software Validations, Failure Investigations, FDA and ISO Inspections, Risk Management, and Supplier Audit/Qualification.  Christy is an AAMI Combination Products Committee Member working on a guidance document for Combination Products Quality Management System.

Gary Gilliam, Operations and Quality Executive, MedPharm Consulting, Inc.

Mr. Gilliam is an operational excellence and quality management systems consultant with 20 years of manufacturing and process improvement experience. He is an innovative operations executive and visionary leader skilled at influencing teams to achieve ambitious business objectives, and has partnered with medical device, pharmaceutical, technology, aerospace, and sheet metal companies around the world. Gary is a Certified Lean Manager as well as a Certified Cultural Transition Facilitator who is able to consistently utilize tools such as value stream mapping, kaizen methodology, and 5S visual management systems to increase productivity and profitability while minimizing waste. Gary also possesses key strengths in analyzing and streamlining processes to reduce cycle time and costs, with additional experience and skills in Change Management, Strategic and Operational Planning and Development, and Quality Excellence. As the former head of Quality Assurance at GE Healthcare, Gary provided leadership for the acquisition and integration of high value diagnostics businesses for entry into the cancer research and laboratory test market; here is responsibilities included but were not limited to business process analysis, quality systems development, and global expansion. He also developed and executed strategies for enterprise integration in support of quality and business objectives; he also successfully integrated a Quality Management System required to obtain a CE Mark in a 9 month period. Gary holds a Bachelor of Science in Business Management, and is also a Certified Lean Six Sigma Blackbelt.

Dinesh Kumar, Regulatory Counsel, Office of Orphan Products Development, Office of Policy and Risk Management, ORA, FDA

Dinesh Kumar is a Regulatory Counsel in the Office of Policy and Risk Management, Office of Regulatory Affairs, at the Food and Drug Administration. Previously, he was a Manager at the research and advisory firm Avalere Health. He received his J.D. from Georgetown University in May 2013, and also holds an M.A. from the University of Chicago and a B.S., cum laude, from Duke University.

Edward Patten, Associate Director Manufacturing Science, Office of Medical Products and Tobacco, Office of Compliance and Biologics Quality, CBER, FDA

Mr. Patten is the Associate Director Manufacturing Science in the Office of Compliance and Biologics Quality, CBER, FDA. He has been with the CBER since July 2008. Mr. Patten regularly works with the Office of Combination Products, including the Part 4 regulation as well as the Guidance for CGMP for Combination Products. Prior to joining FDA, he spent over 25 years in Regulated Industry.


Francisco Vicenty, Mechanical Engineer, Division of Analysis and Program Operations, CDRH, FDA


Jay Jariwala, CSO, Combination Product Expert, OC, CDER, FDA