Place : United States, Fremont
Contact Person:Traininng.com LLC
Description:This webinar will explain about FDA's current inspection and enforcement practices , and also explain how to prepare your company for Part 11 Inspections.
Deadline for abstracts/proposals : 23rd May 2019
Organized By :Traininng.com LLC
Keynote Speakers : 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-
Conference Highlights :FDA's current inspection and enforcement practices FDA's new interpretation: learning from FDA inspection reports Strategy for cost-effective implementation of Part 11: A six step plan Justification and documentation for the FDA and your management Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA a
Venue :Fremont, CA, USA
Check the event website for more details.