ComplianceOnline

Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

Instructor: Kim Huynh-Ba
Product ID: 704421
  • Duration: 90 Min
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This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.

Why Should You Attend:

Current GMP requires organizations maintain label storage condition of drug products throughout the supply chain as part of the Quality Management System (QMS). Regulations and guidelines in this area are not well defined, yet pharmaceutical companies must take necessary steps to maintain quality of clinical supplies or commercial products during transport and distribution.

Shipping of pharmaceutical products could involve long and complex routes that may require temperature controlled environments. Issues such as temperature excursions, packaging breakdowns, incorrect shipping or custom delays could cause detrimental effects and derail critical clinical studies or commercial launch; therefore, it is a challenge to balance between the additional cost of shipping and the product quality.

This webinar will discuss the complexity of the storage and distribution of pharmaceutical products and the effect of environmental factors during transportation and distribution. It will also discuss temperature-cycling studies could be set up to support temperature excursions during shipping of pharmaceutical products depending on their label storage conditions.

Areas Covered in the Webinar:

  • Understand the complexity of transporting and distributing of clinical and commercial products
  • Goal of stability studies and environmental factors
  • Different modes of shipping and distributing of products
  • Risks encountered during transporting and distributing pharmaceutical products
  • Temperature cycling studies to support shipping and storage excursions

Who Will Benefit:

  • Analytical chemists
  • QC managers
  • QA managers
  • Compliance managers
  • Lab managers
  • Sale managers
  • Distributors and manufacturers of raw materials and ingredients
  • Personnel who are responsible with transporting and distributing products through the supply chain

Instructor Profile:

Kim Huynh-Ba has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is currently 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 since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. In 2011-2013, she took a sabbatical from Pharmalytik to join the USP Convention as the Director of Pharmacopeial Education Department, where she was responsible for their education programs worldwide.

Ms. Huynh-Ba 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.

She is a member of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 president. She is the Chair of USP Good Documentation Practices Expert Panel and a member of USP Impurities of Drug Products Expert Panel. Recently, she was elected to be one of the USP Council of Experts (2015-2020).

Ms. Huynh-Ba currently is a member of AAPS Publication Committee, Past-Chair of the Stability Focus Group and serves on the Steering Committees of CMC and Pharmaceutical Trace Impurities Focus Groups. She is an alternate councilor of American Chemical Society-Delaware section. 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 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” (2010).

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