FDA's New Enforcement of 21 CFR Part 11

  • 190.00 Dollar US$
  • Published date: May 23, 2019
    • Fremont, California, United States

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 practices
Reason for changing inspections and enforcement
FDA's new interpretation: learning from FDA inspection reports
How can the new requirements be implemented in your company

Who Will Benefit:
IT Managers and System Administrators
QA Managers and Personnel
Validation Groups
Software Developers
Validation 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: +1-800-447-9407
Email: compliance4all14@gmail.com

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