Strategies to Conduct a Successful Method Transfer according to FDA Expectations

Instructor: Kim Huynh-Ba
Product ID: 705059
  • Duration: 90 Min
This webinar discusses how to execute meaningful Method Transfers by selecting appropriate analytical performance characteristics and acceptance criteria, documentation of the transfer process and how to avoid failures.
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Why Should You Attend:

Analytical methods are a major tool in the pharmaceutical development to control the quality and integrity of the active drug substance or drug product. Methods are typically developed at one site and then transferred to one or more sites for analytical testing. Qualifying a new analytical laboratory is a critical activity that would significantly impact the launch of a product.

This concise session will discuss different strategies to qualify a new laboratory to perform analytical testing and a quality system to maintain GMP compliance throughout the product lifecycle.

Learning Objectives:

  • Understand key factors of analytical procedures
  • Different strategies to quality a QC lab for analytical testing
  • Standardize transfer process to establish method performance
  • Key factors to maintain a compliant quality system.

Areas Covered in the Webinar:

  • Goals of analytical methods
  • Purpose of method qualification
  • Strategies of laboratory qualification
  • Contents of method transfer package
  • Key factors that impact transfer process
  • Documentation of qualification activities

Who Will Benefit:

  • R&D analysts
  • QA and QC Managers
  • Regulatory scientists
  • Directors
  • Manufacturers
  • Laboratory managers
  • Quality managers and personnel
  • Regulatory affairs
Instructor Profile:
Kim Huynh-Ba

Kim Huynh-Ba
Founder and Technical Director, Pharmalytik

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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Analytical Method Validation
Seminars by Ex-FDA Officials

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

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