Risk-Based Software V&V Per U.S. FDA, IEC 62304, GAMP 5 (Reg.) and ISO 14971

Why Should You Attend:

Software / firmware and related hardware design, development, testing / verification and validation is difficult to structure, manage, document and control. For many companies the subject can be intimidating. Software design and development is under increased scrutiny by the U.S. FDA. Software V&V issues are becoming a growing area of concern by all regulatory agencies worldwide. Product, production / test equipment, and even the QMS are heavily software / firmware driven in today's manufacturing. A comprehensive, corporate wide plan, accompanied by proper implementation and documentation, 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 regulatory (FDA and EU) expectations be met?
• What V&V is necessary to minimize software failures in the field or in-house?
• How to use the FDA's own "model" to document all types of SW V&V.
• How to use this model to add predictability to bring software V&V in under budget and within project timelines.

The US FDA requires that all device, production / test / lab equipment, and processes using software / firmware be validated (e.g., 21 CFR 820.70i). Similar for the EU. This presentation focuses on the planning and execution of system-level software verification and validation, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions), that has been field-tested for over 20 years, will be defined, 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 / 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:

• U.S. FDA's expectations
• Tougher FDA Expectations / Requirements
• Data Integrity and Cybersecurity
• Roles of Verification and Validation; Legal requirements; Recommended “best practices”
• A 21-year long, field-tested FDA "Model"
• A Typical Software V&V Protocol / Test Report; "Black" and "White" box testing
• 21 CFR Part 11 (electronic records / signatures) requirements, and its implementation
• Expected Regulatory Deliverables
• Major areas of industry failure
• Standards and industry-recommended Guidelines

Who Will Benefit:

• Senior and middle management.
• Quality Assurance
• Regulatory Affairs
• R&D
• Engineering
• Software engineering
• Programmers
• Sales and Marketing
• Operations / Production

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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