Stability studies need to support shipping and distribution of drugs maintain its identity, strength and purity throughout its expiration. Warning letters, Short term excursion study will be necessary to design shipping condition to maintain quality of drug product through expiry.
Study to Support Shipping and Distributing Pharmaceutical Products Learn the stability studies which need to be done to support shipping and distribution of drugs. Description Why Should You Attend: Drug Product must maintain its identity, strength, quality and purity throughout 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. Upon completion of this session, attendees will learn key factors that would affect the shipping and distribution of drug products. you will understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping condition in order to maintain quality of the drug product through expiry. Areas Covered in the Seminar: 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 or raw material and ingredients Analysts and lab managers QA managers and personnel Regulatory affairs 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. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim 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. Kim serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and will be their 2013 President. Kim 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. Kim 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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