The US FDA's 21 CFR Part 11: Add-on Inspections

On-Demand Schedule Fri, March 01, 2024 - Fri, March 08, 2024
Duration 90 Mins
Level Basic & Intermediate
Webinar ID IQW23G0762

  • US and EU Software V&V requirements. 
  • Cybersecurity and Pt 11 / Annex 11.
  • FDA’s “selective enforcement”.
  • SW / FW V&V ‘model”.
  • FDA and NB SW Inspection / Audit Focus.

Overview of the webinar

“All software, firmware, ladder logic, must be validated” – US FDA. Verification and validation requirements have always been part of the US FDA’s GMPs. Where does 21 CFR Part 11 fit in? Pt 11 “selective enforcement”? “Add on”? Companies still struggle with the performance of and documentation of Equipment, Process, Device, and quality management system / software validations. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful software and hardware validations. The roles of different V&V protocols. Starting with “Requirements”, how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The mandatory, but frequently neglected, 11 documents that must be included in a software V&V. How to address the QMS and 21 CFR Part 11 software issues.

Who should attend?

  • Senior management in FDA/ NB CGMP regulated industries
  • Quality Analysts
  • Research Analysts
  • Research & Development Engineers
  • Engineers
  • Production Managers
  • Operations Managers
  • Marketing Managers

Why should you attend?

What is the US FDA’s expectations for 21 CFR 11, Electronic Records / Electronic Signatures compliance during an FDA CGMP Compliance Inspection?  “Selective enforcement”?  “Add On”? How to develop or improve upon Software Verification and Validation Plan / System that meets IEC 62304, U.S. FDA CGMP, ICH Q-series, and ISO 13485 requirements; based on product use hazard analysis per ISO 14971:2019 and ICH Q9.  The 11 “must have” documents per a US FDA software “model”. Each document is discussed, also test cases where needed, with examples provided that have been field-tested for over 30 years with US and EU regulatory inspectors / reviewers. Suitable for all types of software, et al, whether in simple or complex applications.

Faculty - Mr.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, 27 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.  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, CAPA systems and analysis.  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 ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.


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