Risk and Team-based Integrated Quality Assessment for Generic Sterile Products

Joint meeting with the Sino-American Pharmaceutical Professionals Association

Risk and Team-based Integrated Quality Assessment for Generic Sterile Products

Lynne Ensor, Ph.D. & Bing Cai, Ph.D. (FDA)


Part I (Lynne Ensor):  Sterile drug product manufacturing is a high-risk process which needs to result in the production of drug products free of microorganisms to ensure patient safety and the product’s clinical effectiveness. The vast majority of generic sterile drug products are aseptically manufactured, which poses a greater risk for microbial contamination versus manufacturing the product utilizing terminal sterilization. Since aseptic manufacturing is high-risk and poses more opportunities for contamination, control over the manufacturing practices and facility is critical toward achieving sterility as one of the product’s critical quality attributes. Dr. Lynne Ensor will share insights gained over her twenty years of experience in the regulation of sterile generic drug products. Additionally, she will discuss the challenges surrounding the manufacturing of sterile pharmaceuticals and maintaining their availability, reducing the risks associated with manufacturing processes and facilities, recommendations for designing quality into the manufacturing process and product, and how the Agency utilizes a risk- and team-based approach to perform an integrated quality assessment.

Part II (Bing Cai):  The CDER’s quality initiatives, such as Risk and Team-based Integrated Quality Assessment, have played an important role as part of the 21st Century Initiative to modernize FDA’s regulation of the pharmaceutical quality of drugs to promote a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight. A team of experts work together on application review and pre-approval inspections to generate an integrated quality assessment/decision based on risk, knowledge, and impact to consumer. The risk assessment increases the efficiency and effectiveness of the review by focusing the team on the critical areas and potential failure modes that pose risks to patients. Dr. Bing Cai will discuss the Agency’s expectation on product understanding, risk management and control strategy for development of sterile injectable products and how the Agency utilizes a risk- and team-based approach to conduct an integrated quality assessment for these products. Dr. Cai will also introduce a new OPQ’s initiative on modernization of the quality assessment using a data-based platform for structured quality assessments and applications that supports knowledge management during the lifecycle of a drug product.


Date and Location

Thurs Sept 20th, 2018

Registration & social hour: 5:15 PM
Dinner & presentation: 6:45 PM

Meeting Sponsors

Alcami Corporation

Hanover Marriott

1401 Rt 10 East,
Whippany, NJ 07981

Check out the upcoming 2018 SAPA Annual Conference, Oct 5th-6th, 2018, in Somerset, NJ

About the speakers

Lynne Ensor currently serves as the Deputy Directory (Acting) in the Office of Process and Facilities (OPF) and has been working at FDA since 1998. During her tenure in the FDA’s Center for Drug Evaluation and Research, Lynne worked in the Office of Generic Drugs for 15 years, briefly in the Office of Pharmaceutical Science, and now serves in Office of Pharmaceutical Quality’s Office of Process Facilities. Prior to being responsible for the oversight of OPF’s process, facility, and microbiology assessment of new, generic, and biologic drug products, Lynne’s responsibilities included supervising the OPF Division of Microbiology Assessment. Dr. Ensor earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park. In addition to Dr. Ensor’s regulatory experience at FDA, Lynne served as a clinical medical technologist at Roche Biomedical Laboratories, a post-doctoral research fellow at the University of Maryland at Baltimore’s School of Medicine, and a script consultant for the Discovery Channel.

Bing Cai, Ph.D. joined the FDA as a reviewer within the Office of Generic Drugs (OGD) in 1997. In his twenty-year tenure within the FDA, he has been promoted to CDER Senior Review, Team Lead, Chemistry Division Deputy Director. Currently he serves as Director of the Division of Liquid-based Drug Products (DLBP) in the Office of Life Cycle Drug Products (OLDP), in the Office of Pharmaceutical Quality (OPQ). Dr. Cai has been involved in the development of several important Agency’s initiatives, including the current ANDA Integrated Quality Assessment (IQA). He has coordinated the implementation of the comprehensive review assessment using the Quality by Design and Risk-based Review concepts for various drug dosage forms and complex drug substances to ensure a uniform drug quality program across generic and new drug products. He has also been active in addressing the scientific and regulatory issues raised in controlled correspondences and citizen petitions, in defining regulatory policies that impact ANDAs. He also provides advice on complex generics through pre-ANDA meetings and product specific guidances. He received his Ph.D. in Organic Chemistry from New York University, and a BS degree from Fudan University in China.

Registration Fees

  • Registered and paid online:     $50.00
  • Walk-in:     $65.00
  • Between-positions, Retirees & Students (WITH ADVANCE REGISTRATION ONLY):     $45.00

Advance registration will end at 5:00 PM on WEDNESDAY SEPT 19th;  after that, you must pay at the door.  Note also that if you choose the "Register Now and Pay at Meeting" option, you must proceed all the way to the "Your Order is Confirmed" screen or your registration will not be recorded.

Note: in the event a meeting needs to be cancelled due to weather or other conditions, NJPhAST will do its best to notify all registrants as soon as possible; however, we ask that you exercise individual judgement if you do not hear directly from NJPhAST.

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