Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Why Should You Attend:

Software and related hardware design, development, verification and validation is difficult to manage, document and control. This presentation will focus on the documentation required by the U.S. FDA for 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 field-tested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus of the webcast 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. 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.

Areas Covered in the Webinar:

• Major industry failures
• Tougher FDA expectations / requirements
• Roles of verification and validation
• The 11-element FDA model - and where it's required
• A typical software V&V protocol / test report
• A brief overview of 21 CFR Part 11, ER / ES
• Legacy, hybrid, new, and cloud systems
• Expected regulatory deliverables
• Complementary guidelines, e.g., GAMP

Who Will Benefit:

This information applies to personnel / companies in the pharmaceutical, medical device, diagnostic, nutraceutical and biologics fields. Employees who will benefit include:

• Senior management
• Regulatory affairs
• Quality assurance / QAE
• Production
• Engineering
• R&D
• Software development and testing teams
• All personnel involved in a U.S. FDA-regulated environment
• 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

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 33 years’ experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He 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 so+E6ftware 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 CGMP subjects. He is a graduate of UCLA.

Topic Background:

Software/ firmware 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 resource-intensive V&V activities, in a resource-constrained environment. Risk-based software documentation is the answer. 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?

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