Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples. Those who work with process optimization and validation focus on optimizing a process and reducing variability. Those working on Test Method Validation, on the other hand, focus on discerning between process variation and measurement error from the test method itself.
Often, the test method for a new process must be designed specifically for that process, and some of the pitfalls are in confounding the process itself with the test method. This webinar will present case-studies to explore how those issues are addressed.
Although the FDA provides guidance on method validation, the Code of Federal Regulations (CFR) Title 21 Part 820: Quality System Regulation (QSR) 21 does not specifically broach the topic of method validation. It alludes to it in equipment qualification, statistical methods, process validation, design controls, and other sections. In numerous warning letters, we have witnessed significant importance of method validation as an applicable medical device validation activity. Although, some traditional methods have been applied to chemical, microbial and laboratory acceptance testing methods, they are generally less utilized in the medical device industry.
This webinar will help you better understand Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.
Areas Covered in the Session :
Test Method Validation - Overview
Quality System Regulation, 21 CFR Part 820, and ISO 13485 - Overview
When should Methods be Validated?
Qualification vs Validation
Types of Test Method Validations
How to perform successful test method validations
How to ensure your inspection of verification is effective
Detailing real-life case studies
Understanding global reference standards for test method validation
FDA requirements for TMV
How to prove your inspection method is repeatable and reliable
Recommendations: Some Best Practices and Strategies
Who Will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Research & Development
Quality Engineers and Auditors
Regulatory Affairs Teams
Quality Assurance & Quality Control Teams
Design Assurance Teams
Device Development Teams
Personnel involved in Verification and Validation planning, execution and documentation for devices
José Mora is a Principal Consultant and Project Manager specializing in Manufacturing Engineering, Quality Systems, and Lean Transformations. José is a recognized subject matter expert in process validation, lean manufacturing, lean controlled document systems, startup operations, process development and quality systems, having lectured internationally and presented webinars on these subjects.For over 30 years he has worked in the life sciences in positions ranging from Senior Engineer and Project Manager to Vice-President, specializing in manufacturing, process development, tooling, and quality systems. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.
Wherever he has worked, Jose has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches. He has implemented various good manufacturing practices like JIT, kanban systems, visual workplace and lean manufacturing practices. Jose has also published a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
Principal Consultant and Project Manager
José Mora is a Principal Consultant and Project Manager specializing in Manufacturing Engineering, Quality Systems, and Lean Transformations. José is a recognized subject matter expert in process validation, lean manufacturing, lean controlled document systems, startup operations, process development and quality systems, having lectured internationally and presented webinars on these subjects. His recent consulting engagements have included leading as the Combination Product Development Process coordinator at a Fortune 100 company for the re-design of a major drug-delivery combination product, as well as designing a new Quality Management System for a start-up company that also made combination products. He recently served as acting VP of Operations at Tegra Medical, to help launch a lean transformation, utilizing visual pull signals and other key lean tools. Prior to that, José designed, led, and implemented the lean transformation of three production lines at a top pharmaceutical manufacturer, utilizing visual signals, and Theory of Constraints (TOC) principles. For over 30 years he has worked in the life sciences in positions ranging from Senior Engineer and Project Manager to Vice-President, specializing in manufacturing, process development, tooling, and quality systems.