ComplianceOnline

CFR 21 Part 11 and Annex 11: How to Avoid the Audit Traps

Instructor: Chinmoy Roy
Product ID: 702279
  • Duration: 75 Min

recorded version

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Training CD

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Read Frequently Asked Questions

This webinar on Part 11/Annex 11 audit and enforcement will explain what the auditors are trained to look for during a Part 11/Annex 11 “tag along” audit. It will cover inspection trends with examples of some recent 483s and warning letters and show what one need to do to have a successful inspection outcome.

Why Should You Attend:

The mystery of Part 11 and Annex 11, (henceforth referred to as P11/A11) has dogged the industry ever since the inception of this regulation. Regulatory agencies have stepped up enforcement of P11/A11 through the newly introduced “tag along” audit approach.

This webinar will discover the underlying principles behind P11/A11 regulation. Attendees will receive expert advice on real-world ways to determine what systems and data fall under the scope of P11/A11. It will focus on how auditors are trained to audit P11/A11 and what do they look for during their audits. At the end of this webinar you will become familiar with the intricacies of the regulation so as to ensure that audits of your systems for P11/A11 are citation free.

Areas Covered in the Webinar:

  • Predicate rules and P11/A11 requirements overview
  • What three areas are directly impacted by P11/A11 regulations
  • How to determine which systems and data need to be Part 11 compliant
  • How part 11 compares with Annex 11 and what you need to do to comply with both
  • What P11/A11 SOPs you are required to have ready for the auditors
  • What are auditors trained to look for during a Part 11/Annex 11 “tag along” audit
  • Inspection trends with examples of some recent 483s and Warning Letters

Who Will Benefit:

  • Healthcare Providers
  • Regulatory, QA/QC Personnel
  • Engineering, Manufacturing and Manufacturing Science
  • IT and Software Quality Assurance Personnel
  • Project managers and Validation Consultants

Instructor Profile:

Chinmoy Roy, BSEE, MSCS is an independent engineering and compliance consultant with over 37 years of experience. He is a practicing professional advising companies worlwide. He is an acclaimed trainer and is considered an industry expert in manufacturing automation, CSV, CFR 21 Part 11, QRM, Internal and External audits, and QA of computer systems. His team pioneered the successful implementation and validation of a CFR 21 Part 11 compliant system at a paperless bulk manufacturing control system. This highly complex system was a precursor to FDA’s Part 11 Scope and Application Guidance document in 2003.

He uses examples from his field experience to explain the intricacies of compliance. He has been invited by several worldwide professional organizations to share his experiences through presentation of technical papers and conducting workshops on fundamental principles and evolving nature of computer systems validation and CFR 21 Part 11.

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