The webinar will have the answers. In addition, using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.
Areas Covered in the Session:
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
Who Will Benefit:
QA Managers and Personnel
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.
Event Fee: One Dial-in One Attendee Price: US$150.00