Overview
The tougher FDA expects a company to develop and run a formal software V&V plan . The model presented here satisfies their requirements for all software/firmware/PLC V&V.
Software and related hardware design, development, verification and validation is difficult to manage, document and control. This presnetation focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and growing "cloud"-based software. A suggested FDA model, also accepted by Notified Bodies, will be evaluated, implemented, with V&V documentation and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) In-product, 2) As-product, 3) Production and test, and 4) QMS / 21 CFR Pt. 11, and Cybersecurity. Field examples, good and bad will be addressed. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.
Why Should You Attend
Software design and development is under increased scrutiny by the new "tougher" U.S. FDA. Recently a major pharma company paid a $750 M fine for poor compliance, and software V&V was one of the key contributors. Product, production / test equipment, and even the QMS are heavily software / firmware driven in today's manufacturing. A comprehensive, corporate wide plan is a necessity. Growing "cloud" issues add urgency to upgrade control. Software's complex logic pathways mandate resourse-intensive V&V activities, in a resource-constrained environment. What are the best approaches for companies to take? How can tougher FDA expectations be met? What V&V is necessary to minimize software failures in the field or in-house? How to bring software V&V in under budget and within project timelines.
Webinar Takeaway
- Recent industry failures.
- Tougher FDA Expectations / Requirements
- Roles of Verification and Validation
- An FDA "Model"
- A Typical Software V&V Protocol / Test Report
- A Brief Overview of 21 CFR Part 11, ER / ES
- Legacy, Hybrid, and New Systems
- Expected Regulatory Deliverables
- Complementary Guidelines, e.g., GAMP
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
- Production
- Engineering, R&D, and software development and testing teams
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.
