Original broadcast date: Wednesday June 8, 2016

Presenter: Ludwig Huber

The FDA has released a new comprehensive guidance for validation of analytical methods. The guidance applies the modern integrated lifecycle approach with related new requirements for using quality-by-design components, risk assessment, design space, and continuous improvement. The guidance will significantly change how FDA regulated methods will be developed, validated, and used. Because of the novelty of some of the concepts, the industry will have difficulties in understanding and implementing the guidance.

As an attendee, you will learn more about:

  • Scope and content of the guidance
  • FDA’s approach for method validation
  • Lifecycle management of analytical procedures
  • Parameters to be validated
  • Analytical method transfer studies
  • Documentation requirements

Ludwig Huber, PhD, is a director at Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems." He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, and validation around the world. This included seminars, workshops, and presentations for the US FDA, China CFDA, ISPE, Japan PDA, PIC/S, and several other national health care agencies.


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