FDA's New Enforcement of 21 CFR Part 11

Overview:The webinar will have the answers. And 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.
Why should you Attend:There are many questions about the P11 inspection program, e.g., what inspectors are looking at and what major findings are. The seminar 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 past inspection and enforcement practicesReason for changing inspections and enforcementFDA's new interpretation: learning from FDA inspection reportsHow can the new requirements be implemented in your company
Who Will Benefit:IT Managers and System AdministratorsQA Managers and PersonnelValidation GroupsSoftware DevelopersValidation Professionals
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".
Event Fee: One Dial-in One Attendee Price: US $190.00
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: compliance4all14@gmail.com