Software Verification and Validation Planning to Meet CGMP Requirements

Why Should You Attend:

Software and related hardware design, development, verification and validation is difficult to manage, document and control.

This presentation 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 will be evaluated, implemented, with V&V documentation and test case examples.

The focus will be on the most recent issues the FDA has had in this area, and remediation approaches. Software considered include: 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.

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.

Areas Covered in the Seminar:

• 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.
• Legacy, Hybrid, New and ER / ES Systems.
• Expected Regulatory Deliverables.
• Complementary Guidelines, e.g., GAMP.

Who Will Benefit:

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
• Quality Assurance
• Production / QAE
• 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 equipment that are software driven, companies with quality management / MRP / ERP systems moving toward "paperless" systems, or other regulated medical products activities.

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 years as a full-time consultant. John has worked with companies from start-up o 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, conducted workshops and webinars worldwide on all CGMP subjects. John is a graduate of UCLA.