Understanding and Preparing for FDA's on-going Part 11 Inspections - Recorded Webinar

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Webinar Duration: 75 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Ludwig Huber

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last four years FDA has issued more than 30 warning letters with Part 11 deviations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems.

There are many questions about the program, e.g., what inspectors are looking at and what are major findings. The seminar 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.

Areas Covered in the Session:
- FDA's current inspection and enforcement practices
- FDA's new interpretation: learning from FDA inspection reports
- Part 11 and the new EU Annex 11: similarity and differences
- Strategy for cost-effective implementation of Part 11: A six step plan
- Recommended changes to existing Part 11 programs to reduce costs
- Justification and documentation for the FDA and your management
- 6 Case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.
- Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.
- How to prepare for Part 11 Inspections

Who Will Benefit:
- IT managers and system administrators
- QA managers and personnel
- Analysts and lab managers
- Validation groups
- Software developers
- Validation professionals
- Training departments
- Documentation departments
- Consultants

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. For more information, please visit Dr. Huber’s website www.ludwig-huber.com

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