Medical Device Non-Product Software Validation Training

Why Should You Attend:

Software design, development, implementation and use is under increased scrutiny by a "tougher" U.S. FDA. Software V&V issues are becomming a growing area of concern by regulatory agencies. Product production / test equipment, and even the QMS are heavily software / firmware driven in today's manufacturing. Part 11 and cybersecurity are often important considerations. 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, demanding a risk-based approach. What are the best approaches for companies to take? How can tougher expectations be met? What V&V is necessary to minimize software failures? Use the FDA's own "model" to document all types of SW V&V. And use this model to add predictability to bring software V&V in under budget and within project timelines.

Areas Covered in the Webinar:

• Major areas of industry failure
• Tougher FDA Expectations / Requirements; Cybersecurity
• Roles of Verification and Validation
• An FDA "Model"
• A Typical Software V&V Protocol / Test Report; "Black" and "White" box
• A Brief Overview of 21 CFR Part 11, and its implementation
• Legacy, Hybrid, New and ER / ES Systems
• Expected Regulatory Deliverables
• Cybersecurity

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated device production software / firmware 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 produiction equipment and process validation projects. This information applies to personnel / companies in the Medical Device and some Combination 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 productioin / test equipment that are software driven, companies with quality management / MRP / ERP systems moving toward "paperless" systems, or other regulated medical products / CGMP and ISO QMS activities.

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 ptublished 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.

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