Faculty John E Lincoln
Principal, J E Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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. 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.
Overview
Regulated CGMP companies must develop / implement a formal CSA, Computer Software Assurance program per the FDA's new Guidance Document.
Software and related hardware design, development, verification and validation is difficult to manage, document and control. This presentation focuses on the verification and validation planning and execution of software under FDA's new CSA requirements, and after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf), custom, and the growing field of "cloud"-based software. A suggested CSAS compliant FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus is on the CSA Guidance on QMS/system-wide compliance and remediation approaches. 21 CFR Pt. 11, cybersecurity, ML/AI issues will be considered. Field examples, good and bad will be addressed. Evaluation of the chief areas of the FDA's new "Computer Software Assurance for Production and Quality Management System Software" Guidance Document issued on February 3, 2026, is the focus.
Why Should You Attend
Software used in CGMP activities are under increased scrutiny by a "tougher" U.S. FDA. The QMS, product, production / test equipment, are heavily software / firmware driven in today's manufacturing. A comprehensive, corporate wide plan is a necessity, and now a formal US FDA requirement. Growing "cloud" issues add urgency to upgrade control. Software's complex logic pathways mandate resourse-intensive V&V activities, in a resource-constrained environment, demanding a product risk-based approach. What are the best approaches for companies to take? How can tougher FDA expectations be met? What V&V and averall CSA activities are necessary to minimize software failures in the company, and meet these new FDA requirements?
Webinar Takeaway
- The FDA's new "Computer Software Assurance for Production and Quality Management System Software" Guidance , Feb 03, 2026.
- Tougher FDA Expectations / Requirements
- Roles of Verification and Validation
- An FDA "Model" and IEC 62304 – medical device software
- A Typical Software V&V Protocol / Test Report
- 21 CFR Part 11, Cybersecurity, ML/AI Concerns
- Legacy, Hybrid, New and ER / ES Systems
- Expected Regulatory Deliverables
- Complementary Guidelines, e.g., GAMP® 4 & 5
Who Will Benefit
This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing "cloud" environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects. This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical and Biologics fields. The employees who will benefit include:
- Senior management
- Regulatory Affairs
- Quality Assurance / QAE
- Production
- Engineering, R&D, and software development and testing teams
All personnel involved in a U.S. FDA-regulated environment. Especially those involved in new product development with products and equipment that are software driven, companies with quality management / MRP / ERP systems moving toward "paperless" systems, or other regulated medical products activities.
