Mastering Test Method Validation (TMV) for Medical Devices: Ensuring Compliance and Performance
Is Your TMV Protecting Against Hidden Compliance Pitfalls?
Instructor :
Jose Mora
Webinar ID:
11613
Date: OCT 22, 2024 (TUE)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What will you learn
-
- Test Method Validation – Comprehensive Overview
- Global Reference Standards And FDA Requirements For Validation
- Quality System Regulations (21 CFR Part 820) And ISO 13485 Overview
- Timing And Necessity Of Method Validation
- Understanding Qualification Vs. Validation
- Types Of Test Method Validations Explained
- Executing Successful And ….
-
- Test Method Validation – Comprehensive Overview
- Global Reference Standards And FDA Requirements For Validation
- Quality System Regulations (21 CFR Part 820) And ISO 13485 Overview
- Timing And Necessity Of Method Validation
- Understanding Qualification Vs. Validation
- Types Of Test Method Validations Explained
- Executing Successful And Reliable Test Method Validations
- Ensuring Effective And Repeatable Inspection Or Verification Methods
- Real-Life Case Studies And Best Practices
Course Description
Test Method Validation (TMV) is a critical yet often misunderstood requirement for medical devices.
Understanding its intricacies is essential for ensuring your device’s performance and regulatory compliance.
Key Highlights:
-
- Understanding the Role-Reversal: While a defect-free process is the goal, a test method must be robust in detecting defects without rejecting acceptable samples.
- Process vs. Measurement: Learn how to differentiate between process variation and measurement error, a crucial skill for those involved in Test Method Validation.
- Designing for Specific Processes: Discover the challenges and solutions in designing test methods tailored for new processes, avoiding common pitfalls like confounding the process with the test method.
- Case Studies: Real-world examples will illustrate how to address these issues effectively, offering practical insights you can apply immediately.
- Regulatory Guidance: Although the FDA provides guidance, Title 21 CFR Part 820: Quality System Regulation (QSR) doesn’t specifically cover method validation. However, it’s implied in various sections like equipment qualification, statistical methods, and design controls.
- Industry Insights: Learn from warning letters and industry practices that underscore the significance of method validation as an essential medical device validation activity.
Gain a comprehensive understanding of TMV and its application in the medical device industry. This webinar will equip you with the knowledge to enhance your device’s reliability, compliance, and market success.
Join Now!
Test Method Validation (TMV) is a critical yet often misunderstood requirement for medical devices.
Understanding its intricacies is essential for ensuring your device’s performance and regulatory compliance.
Key Highlights:
-
- Understanding the Role-Reversal: While a defect-free process is the goal, a test method must be robust in detecting defects without rejecting acceptable samples.
- Process vs. Measurement: Learn how to differentiate between process variation and measurement error, a crucial skill for those involved in Test Method Validation.
- Designing for Specific Processes: Discover the challenges and solutions in designing test methods tailored for new processes, avoiding common pitfalls like confounding the process with the test method.
- Case Studies: Real-world examples will illustrate how to address these issues effectively, offering practical insights you can apply immediately.
- Regulatory Guidance: Although the FDA provides guidance, Title 21 CFR Part 820: Quality System Regulation (QSR) doesn’t specifically cover method validation. However, it’s implied in various sections like equipment qualification, statistical methods, and design controls.
- Industry Insights: Learn from warning letters and industry practices that underscore the significance of method validation as an essential medical device validation activity.
Gain a comprehensive understanding of TMV and its application in the medical device industry. This webinar will equip you with the knowledge to enhance your device’s reliability, compliance, and market success.
Join Now!
Why you should attend
This webinar offers a deep dive into Test Method Validation (TMV) to ensure the effective performance verification of medical devices.
It covers global reference standards, FDA requirements, and the practical steps to execute a successful TMV, all backed by detailed real-life case studies.
What Sets This Webinar Apart?
Unlike many resources that are overly theoretical, focusing heavily on statistics, Gauge R&R, and Measurement System Analysis, this webinar stands out by drawing on first-hand experience. You’ll gain insights from real-world challenges and failures—valuable lessons that aren’t often covered in other webinars.
Common Misconceptions About TMV:
Many professionals overlook TMV due to various assumptions:
-
- It doesn’t apply to their situation: They believe TMV is not relevant to their specific context.
- Using ASTM standards eliminates the need for validation: They mistakenly think that adherence to ASTM standards negates the need for objective evidence of their setup and results.
- Reliance on past data: They assume past data can be leveraged without realizing that the measurement system that generated that data may have been flawed.
- R&D testing doesn’t require TMV: They assume TMV is unnecessary for research and development, not recognizing that without a valid measurement system, their research could be compromised.
- Process validation suffices: They think that once the process is validated, there’s no need to revalidate the measurement system.
These misconceptions can lead to critical oversights, making this webinar an essential training for professionals involved in medical device validation.
Enroll Now!
This webinar offers a deep dive into Test Method Validation (TMV) to ensure the effective performance verification of medical devices.
It covers global reference standards, FDA requirements, and the practical steps to execute a successful TMV, all backed by detailed real-life case studies.
What Sets This Webinar Apart?
Unlike many resources that are overly theoretical, focusing heavily on statistics, Gauge R&R, and Measurement System Analysis, this webinar stands out by drawing on first-hand experience. You’ll gain insights from real-world challenges and failures—valuable lessons that aren’t often covered in other webinars.
Common Misconceptions About TMV:
Many professionals overlook TMV due to various assumptions:
-
- It doesn’t apply to their situation: They believe TMV is not relevant to their specific context.
- Using ASTM standards eliminates the need for validation: They mistakenly think that adherence to ASTM standards negates the need for objective evidence of their setup and results.
- Reliance on past data: They assume past data can be leveraged without realizing that the measurement system that generated that data may have been flawed.
- R&D testing doesn’t require TMV: They assume TMV is unnecessary for research and development, not recognizing that without a valid measurement system, their research could be compromised.
- Process validation suffices: They think that once the process is validated, there’s no need to revalidate the measurement system.
These misconceptions can lead to critical oversights, making this webinar an essential training for professionals involved in medical device validation.
Enroll Now!
Areas Covered
-
- Test Method Validation – Overview
- Understanding Global Reference Standards for Test Method Validation
- Quality System Regulation (21 CFR Part 820) and ISO 13485 – Overview
- FDA Requirements for Test Method Validation
- When Should Methods Be Validated?
- Qualification vs. Validation
- Types of Test Method Validations
- How to Perform Successful Test Method Validations
- How to Prove Your Inspection Method Is Repeatable and Reliable
- How to Ensure Your Inspection or Verification Is Effective
- Detailing Real-Life Case Studies
- Recommendations: Best Practices and Strategies
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
-
- Test Method Validation – Overview
- Understanding Global Reference Standards for Test Method Validation
- Quality System Regulation (21 CFR Part 820) and ISO 13485 – Overview
- FDA Requirements for Test Method Validation
- When Should Methods Be Validated?
- Qualification vs. Validation
- Types of Test Method Validations
- How to Perform Successful Test Method Validations
- How to Prove Your Inspection Method Is Repeatable and Reliable
- How to Ensure Your Inspection or Verification Is Effective
- Detailing Real-Life Case Studies
- Recommendations: Best Practices and Strategies
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Research & Development
- Quality Engineers and Auditors
- Manufacturing Engineers
- Regulatory Affairs Teams
- Quality Assurance & Quality Control Teams
- Operations Teams
- Document Control
- Design Assurance Teams
- Device Development Teams
- Personnel involved in Verification and Validation planning, execution and documentation for devices
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Research & Development
- Quality Engineers and Auditors
- Manufacturing Engineers
- Regulatory Affairs Teams
- Quality Assurance & Quality Control Teams
- Operations Teams
- Document Control
- Design Assurance Teams
- Device Development Teams
- Personnel involved in Verification and Validation planning, execution and documentation for devices
Instructor Profile
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.
Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, Kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. 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, orthopedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership.
He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he 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.
