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.
So far there has not been an official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published a proposal for a general chapter < 1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. The USP chapter will become official with USP 35. Now it is a good time to learn how to conduct and document method transfer. This webinar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation.
Speaker
Dr. 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
Who Should Attend
- Analysts
- Lab Supervisors and Managers
- QA Managers and Personnel
- Consultants
- Teachers
