Stability Program to Support Shipping and Distribution of Drug Products

Why Should You Attend:

A drug product must maintain its identity, strength, quality and purity till its expiration. Physical, chemical and biological data are influenced by various environmental factors such as temperature, humidity and light. In current manufacturing environment, products can be shipped and distributed across different climatic zones. Seasonal changes as well as types of transportation can greatly affect the supply chain of the products.

This webinar will outline stability studies to support shipping and distribution of drug products. On completing this session, attendees will learn key factors that would affect the shipping and distribution of drug products. Participants will understand product stability profile, typical environmental conditions for storage, and anticipating environmental extremes for distribution. This information will be necessary to design shipping conditions in order to maintain quality of the drug product till expiry.

Areas Covered in the Webinar:

• Goal of stability studies.
• Warning letters and observations on shipping and distribution practices.
• Short term excursion study.
• Thermal cycling study.
• Analytical testing for these studies.

Who Will Benefit:

• Pharmaceutical scientists
• Manufacturers of raw material and ingredients
• Analysts and lab managers
• QA managers and personnel
• Regulatory affairs personnel

Instructor Profile:

Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is the executive director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies including companies operating under FDA’s consent decree on harmonization and optimization of analytical best practices. Prior to this position, she was the director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Ms. Huynh-Ba has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an adjunct professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology teaching pharmaceutical analyses and analytical chemistry graduate courses.

Ms. Huynh-Ba serves on the executive committee of the governing board of Eastern Analytical Symposium (EAS) and will be their president for 2013. She is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award.

Ms. Huynh-Ba has authored numerous technical publications and book chapters and has spoken extensively, both domestic and globally, in the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010).

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