Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al
Description
Review a company's Test Method and Design Verification and Validation system for major GLP (Good Laboratory Practices) deficiencies. One major failing is lack of sufficient or targeted risk-based V&V planning and associated documentation. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 / ICH Q9 for hazard analysis and product risk management, allows the development of science-based analytical Test Methods validation. Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents. Our matrix examples simplify "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 and cybersecurity are considered where required.
Why Should You Attend:
FDA Warning Letters and recent high-profile recalls indicate P deficiencies in GLP test method / device design verification and validations. What are the regulatory requirements? One major failing is lack of sufficient or targeted risk-based process V&V planning / execution. The "must have" elements from ISO 14971 for hazard analysis and product / process risk management. Integration of test method validation essentials into a company's quality management system, specifically its development and use of analytic test methods and V&V activities.
Areas Covered in the Webinar:
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Participants will learn how an effective Test Method Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety.
Issues to be covered include:
- Assurance of product quality from CGMP test method compliant validation
- FDA Analytical Test Method V&V guidelines
- Basic GLP requirements
- Understand the scope of regulations governing test method / design validation and identify gaps
- Develop a plan to rectify existing validation plans, protocols and reports
- Learn how to construct, implement and deploy a Validation Master Plan
Instructor Profile:
John E Lincoln
Principal, J E Lincoln and Associates
Principal, J E Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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.