Overview:
Test
Method Validation (TMV) is a critical yet often misunderstood requirement in
the medical device industry. A key challenge lies in the role reversal between
the test method and the product or process it is meant to assess. For instance,
while achieving a defect-free process is the goal, a reliable test method must
be equally adept at identifying defects and confirming the acceptability of
good samples. This contrasts with process optimization, where the focus is on
minimizing variability. TMV, however, centers on distinguishing between process
variation and measurement errors inherent in the test method itself.
In
many cases, new processes require the development of specialized test methods,
which can lead to the conflation of process issues with those of the test
method. This webinar will use case studies to illustrate how these challenges
can be effectively 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 explicitly
address method validation. Instead, it is indirectly referenced in areas such
as equipment qualification, statistical methods, process validation, and design
controls. Recent FDA warning letters have highlighted the increasing importance
of method validation as a critical aspect of medical device validation. While
traditional validation methods are well-established in chemical, microbial, and
laboratory acceptance testing, they are often underutilized in the medical
device sector. This session will bridge that gap, providing you with the
necessary tools to ensure that your test methods are both reliable and
compliant with current regulatory expectations.
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
Why should
you attend?
In
the highly regulated medical device industry, ensuring that your test methods
are both accurate and reliable is not just a best practice—it's a regulatory
necessity. As industry standards evolve and FDA scrutiny increases, the ability
to effectively validate your test methods can make the difference between a
product that passes inspection and one that faces costly delays or rejections.
This
webinar will equip you with the knowledge and tools to navigate the
complexities of Test Method Validation (TMV), helping you to avoid common
pitfalls that could compromise the quality and compliance of your products.
Whether you are involved in process development, quality assurance, or
regulatory affairs, this session will provide you with actionable insights to
enhance your TMV practices. Through real-world case studies and practical
guidance, you will learn how to distinguish between process variations and
measurement errors, ensuring that your test methods are robust and meet the
highest standards of regulatory compliance.
By
attending, you will gain a deeper understanding of the critical role TMV plays
in the medical device lifecycle and how to apply the latest industry
developments to your validation efforts. This is an essential session for
professionals who want to stay ahead of the curve and ensure the success of
their medical devices in today's competitive market.
Who
will benefit?
This
webinar is designed for professionals involved in the development, validation,
and regulation of medical devices. Key roles that will benefit include:
- Quality
Assurance Managers
- Quality
Control Engineers
- Regulatory
Affairs Specialists
- Process
Development Engineers
- Validation
Engineers
- Test
Method Developers
- Compliance
Officers
- Design
Engineers
- Manufacturing
Engineers
- Laboratory
Managers
- R&D
Scientists
- Medical
Device Project Managers
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, orthopaedic 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.