Software Validation and its 11 Key Documents

Why Should You Attend:

Software design and development is under increased scrutiny by a "tougher" U.S. FDA. Software V&V issues are becoming 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. A comprehensive, corporate wide plan is a necessity. Growing "cloud" issues add urgency to upgrade control. Software's complex logic pathways mandate resource-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 is necessary to minimize software failures in the field or in-house? 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..

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated 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 validation projects. This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceutical and Biologics fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• Engineering

All personnel involved in a U.S. FDA-regulated environment. Especially those involved in the complaing handling, non-conforming material, out-of-specification, failure investigations, root cause analysis, labeling, distribution, storage, tracking, use or regulated medical products.

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 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln 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, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published 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. Mr. Lincoln is a graduate of UCLA.

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