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This webinar focuses on 21 CFR Part 11 requirements stipulated by the FDA. It will also guide attendees on writing corrective and preventive action plans as follow up to 483s.
Why Should You Attend:
Some time ago, FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. At the beginning of the initiative, FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the guidance from 2003. In the meantime, FDA officials reported key findings, and inspectors regularly cited deviations related to computer validation and other Part 11 issues. Due to lack of clear guidance from the FDA, the industry has lots of questions. Using recent warning letters as examples, this webinar will demonstrate how current Part 11 requirements will be met.
Backed by strong, informative content on the subject, attendees will enjoy the advantage of detailed instruction on the subject and addressing frequently asked industry queries on the topic as well.
For easy implementation, attendees will receive:
Areas Covered in the Webinar:
Who Will Benefit:
Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He has authored 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 includes seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national healthcare agencies.
Contact for Registration: