USFDA India Seminar 2011 at Mumbai on Validation and 21 CFR Part 11 Compliance of Computer Systems

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Uploaded by on Aug 4, 2011

Dr. Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the on-line resource for validation and global FDA compliance. He is also the author of the bestselling books "Validation of Computerized Analytical and Networked Systems " and "Validation and Qualification in Analytical Laboratories,". Currently, Dr. Huber is on the Scientific Advisory board of IVT´s GxP and Validation Journals, and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars and presentations for the US FDA, ISPE, PDA, PIC/S and several national health agencies. Dr. Huber also received the "First International GLP Award" from Indian Drug Manufacturer Association for presentations and publications about GLP and GMP

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