Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

Why Should You Attend:

Some time ago, FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. At the beginning of the initiative, FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the guidance from 2003. In the meantime, FDA officials reported key findings, and inspectors regularly cited deviations related to computer validation and other Part 11 issues. Due to lack of clear guidance from the FDA, the industry has lots of questions. Using recent warning letters as examples, this webinar will demonstrate how current Part 11 requirements will be met.

Backed by strong, informative content on the subject, attendees will enjoy the advantage of detailed instruction on the subject and addressing frequently asked industry queries on the topic as well.

Hand-outs:

For easy implementation, attendees will receive:

• Checklist: Part 11 compliance
• Case studies: How to avoid Part 11 related 483s and Warning Letters
• SOP: Electronic audit trail - specifications, implementation, validation

Note: These complimentary hand-outs will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.

Areas Covered in the Webinar:

• FDA inspections - preparation, conducts, follow up
• The meaning of Warning Letters and 483 inspectional observations
• Learning from an FDA presentation: Data Integrity and Fraud - Another Looming Crisis?
• Data integrity and authenticity: FDA's new focus during inspections
• Examples of recent Part 11 related 483s and Warning Letters
• Examples of recent 483s and Warning Letters related to computer system validation
• Most obvious reasons for deviations
• Avoiding and responding to 483s: going through case studies
• Writing corrective and preventive action plans as follow up to 483s
• Using internal audits to prepare yourself for Part 11 related FDA inspections
• Strategies and tools for compliant Part 11 implementation
• The future of Part 11 and computer system validation

Who Will Benefit:

• Personnel from the pharmaceutical and medical device industry
• Manufacturers of drug substances (APIs)
• Contract laboratory staff
• Employees using computers in FDA regulated environments
• IT managers and staff
• QA managers and personnel
• Quality control directors or delegates
• Regulatory affairs personnel
• Training department personnel
• Consultants
• Validation specialists

Dr. Ludwig Huber
Director and Chief Editor, Labcompliance

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, 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." He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and validation around the world. This includes seminars, workshops and presentations for the US FDA, China CFDA, , ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.

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