- TypeWebinar
- Location Fresno, California, United States
- Date 18-05-2017
Education/Teaching/Training/Development
Advertising/Marketing
Manufacturing
Medical/Healthcare/Hospital
Overview:
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria. This seminar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.
For easy implementation, attendees will receive:
Areas Covered in the Session:
Who Will Benefit:
Speaker Profile
Ludwig Huber Ph.D., is the director and editor of Labcompliance 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, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com
For more details and updates please visit webinar website
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