FDA continues to enforce through its new 21 CFR Part 11 inspection

Overview: 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: QC Managers QA Managers and Personnel IT Administrators Analysts Regulatory Affairs Training Departments Documentation Department Consultants Speaker Profile: 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 Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com