FDA’s 21 CFR Part 11 Add-on Inspections

The verification and validation of cGMP software is coming under increased scrutiny by the U.S. FDA.  This webinar will address the use of U.S FDA Guidance, GAMP, 21 CFR 11, Electronic Records / Signatures, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. Just what are "add-on inspections".

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 in effect  eliminated it's "selective enforcement" policy / "add-on" inspections, and is looking for proper implementation of the control of electronic records and electronic signatures, per "predicate rules", 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.

WHY YOU SHOULD ATTEND:

The verification and validation of electronic records and electronic signature software is coming under increased scrutiny by the U.S. FDA.  This webinar will address the use of FDA Guidances, GAMP®, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", 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 validation can realistically only be accomplished effectively if “risk-based”.  How can this be accomplished in the real world.

This webinar will address software that is supporting the company's Quality System and cGMP documentation.  It will assist in evaluating software vendor and "cloud" software 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 in the Session :

• Verification or Validation
• Current  Regulatory Expectations  and Recent Audit “Hot Buttons”
• The Part 11 Project Validation Plan
• The Simplified Approach to 21 CFR Part 11 Compliance 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
• GAMP® / IEC 62304 considerations

Who Should Attend:

This webinar will provide valuable assistance to all the personnel / companies in the Medical Devices, Diagnostic, and to a lesser extent the Pharmaceutical and Biologics fields. The employees who will benefit include:

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operations
• Consultants
• cGMP instructors
• All personnel especially involved in product, process, validations, cGMP responsibilities

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace.  He has published numerous articles in peer reviewed journals / books, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.