Studies to Support Temperature Excursions and Shipping Of Pharmaceutical Products

Kim Huynh-Ba

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The Webinar will discuss the global nature of the pharmaceutical distribution supply chain and how temperature cycling studies can be done to support temperature excursions and shipping of drug products.

Course Objective

Shipping pharmaceutical products is more complicated than shipping any other items.  Current GMP requires organizations maintain good storage and/or distribution practices of drug products throughout the supply chain as part of Quality Management System (QMS).  There are specific guidelines and regulations involved in shipping as there are necessary steps to ensure that quality of the drug products are not compromised before they reach the consumer.

Temperature is a primary concern when shipping pharmaceuticals.  Products must be shipped in containers that are well insulated.  Temperature controlled shipments ensure that drug product are kept in optimal condition. Direct, non-stop routes are used to ensure that delivery is secured as well as other logistic considerations such as cameras in the warehouse, satellite tracking or visibility.

Course Outline

  • Introduce an overview and complexity of the storage and distribution of pharmaceutical products
  • Review observations on shipping practices
  • Goal of stability studies and environmental factors
  • Establish temperature cycling studies
  • Analytical testing for these products

Target Audience

Analytical chemists, QC managers, QA managers, compliance managers, lab managers, sale managers, distributors, manufacturers of raw materials and ingredients, and individuals who are responsible with storage, shipping and distributing products through the supply chain.

Learning Objectives:
Upon completion of this session, attendees will learn key factors that would affect the shipping and distribution of drug products.  One must 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.

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Kim Huynh-Ba,

Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDAs Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, 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 (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses. Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and is their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-15). She was also a member of USP General Chapter Expert Committee (2010-15), member of USP Reference Standard Project Team and USP Prescription/Non-Prescription Stakeholder Forum of previous cycle. She was a member of the Consumer Healthcare Product Associations (CHPA) Stability and Impurities Breakout Groups. Kim currently is a member of AAPS Publication Committee, Chair of the Stability Focus Group and serves on the Steering Committees of CMC and Pharmaceutical Trace Impurities Focus Groups. 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 internationally, of 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

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