21 CFR Part 11 and AI

The verification and validation of electronic records and electronic signature software is coming under increased scruinty by the U.S. FDA. This webinar will address the use of FDA Guidances, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", FDA's AI_Framework, and FDA expectations for the use of AI in developing V&V protocols, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable cGMP Part 11 software validations.  The FDA and other regulatory agencies have stated that software validaiton can realisticly only be accomplished effectively if “risk-based”.

This webinar will address software that is supporting the company's Quality System and cGMP documentation.  It will assist in evaluating software vendor claims to separate compliant software from "vaporware". A manufacturer is responsible to identify these requirements and implement them into an effective 21 CFR Part 11 CGMP software V&V process.

Areas Covered

• Verification or Validation
• Current  Pt 11 and AI Regulatory Expectations  and Recent Audit “Hot Buttons”
• The Part 11 Project Validation Planning
• The Simplified Approach to 21 CFR Part 11 Compliance, AI,  and Software V&V
• When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
• Simplified Sample V&V Test Cases and their Development
• The FDA’s 10 Key V&V Documentation Elements
• Chat GPT Sample Prompts

Background

The verification and validation of CGMP software, especially AI-enabled,  is coming under increased scrutiny by the U.S. FDA. This webinar will address the use of U.S. FDA Guidance,  21 CFR 11, AI framework, and use of AI to develop V&V protocols,  and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation.

Why Should You Attend

Software has become pervasive in medical product manufacturing documentation and cGMP compliance actions, and in the controlling, running, and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics, or dietary supplements industries.  Software is being developed for routing, managing, approving, and signing all manner of cGMP documentation, maintenance of "controlled documents" as well as their update and archiving.

The U.S. FDA has eliminated its "selective enforcement" policy and is looking for proper implementation of the control of electronic records and electronic signatures, that can withstand legal review in a court of law. Companies may try to say they are using "hard copies" as their controlled documents, but this is increasingly becoming a wrong belief as employees use the electronic versions to make and implement cGMP decisions.

Regulatory auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the dangers of neglecting thorough, and risk-based Part 11 software verification and validation activities.   Simple but effective and real-world 21 CFR Part 11 software V&V is even more important in today’s resource-constrained industrial environment.

Who Should Attend

• Senior management in Drugs, Devices, Biologics, Dietary Supplements 
• QA
• RA
• R&D
• Engineering
• Production
• Operations
• Consultants; others tasked with CGMP process and electronic records/signatures software V&V responsibilities.