Risk-Based Verification and Validation Planning to Meet U.S. FDA, ICH Q9 and ISO 14971

Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Why do companies need a Master Validation Plan? What are the must have elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into a company's quality management system.

Attend this Webinar to know how to review a company's Master Validation Plan for major cGMP deficiencies. How to address the FDA's newer and tougher regulatory stance. How to create a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management and develop meaningful product and process validations. Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources. A matrix simplifies "as-product", in-product", process and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 will be discussed.

Areas Covered in the Seminar:

• Verification or Validation -- Recent regulatory expectations.
• The Master Validation Plan.
• Product V&V versus Process / Equipment V&V.
• When and How to Use DQ, IQ, OQ, PQ.
• Using the Risk Management tools of ISO 14971 and ICH Q9.
• The 11 Elements of the Software VT&V "Model".
• Avoid recent "horror stories" and multimillion dollar fines.

Who Will Benefit:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• Engineering, including Software
• All personnel involved in verification and/or validation planning, execution and documentation

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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 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. John is a graduate of UCLA.