Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
90 Minutes
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 guides 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 the 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.
WHY SHOULD YOU ATTEND?
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.
AREA COVERED
- 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
- 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
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.
- 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
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
Speaker Profile
Jose Ignacio Mora
Jose 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 …
Upcoming Webinars
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
By:Bob McKenzie
Sept. 12, 2024
12:00 PM PDT | 03:00 PM EDT
6-Hour Virtual Seminar on Learning the Highlights of Excel …
By:Cathy Horwitz
Sept. 12, 2024
10:00 AM PDT | 01:00 PM EDT
Impact Assessments For Supplier Change Notices
By:Alan M Golden
Sept. 12, 2024
10:00 AM PDT | 01:00 PM EDT
Developing an FDA/ISO Compliant Quality Management System
By:Ms. Marie Dorat
Sept. 13, 2024
10:00 AM PDT | 01:00 PM EDT
Aligning Your HR Strategy with Your Business Strategy
By:Pete Tosh
Sept. 13, 2024
12:00 PM PDT | 03:00 PM EDT
Accounting For Non Accountants : Debit, Credits And Financi…
By:Richard E Cascarino
Sept. 13, 2024
10:00 AM PDT | 01:00 PM EDT
I-9 Audits: Strengthening Your Immigration Compliance Strat…
By:Diane L. Dee
Sept. 16, 2024
12:00 PM PDT | 03:00 PM EDT
Managing Difficult Employee Conversations
By:Audrey Halpern
Sept. 16, 2024
10:00 AM PDT | 01:00 PM EDT
Dealing With Difficult People In Life & Work
By:Paul J. Cline
Sept. 16, 2024
10:00 AM PDT | 01:00 PM EDT
Predictive Accounting: Driver-Based Budgeting And Rolling F…
By:Gary Cokins
Sept. 17, 2024
10:00 AM PDT | 01:00 PM EDT
Pay Equity Changes for 2024! What Employers Need to Know to…
By:Margie Faulk
Sept. 17, 2024
12:00 PM PDT | 03:00 PM EDT
Leader Branding: How to Communicate with Confidence to Attr…
By:Dr. Agustin Rosa Marin
Sept. 18, 2024
10:00 AM PDT | 01:00 PM EDT
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
By: Carolyn Troiano
Sept. 19, 2024
12:00 PM PDT | 03:00 PM EDT
Project Management for Non-Project Managers - How to commun…
By: Charles H. Paul
Sept. 19, 2024
10:00 AM PDT | 01:00 PM EDT
Why EBITDA Doesn't Spell Cash Flow and What Does
By:Dev Strischek
Sept. 19, 2024
12:00 PM PDT | 03:00 PM EDT
Design Verification, Validation and Testing for Medical Dev…
By:Meena Chettiar
Sept. 19, 2024
12:00 PM PDT | 03:00 PM EDT
FFIEC BSA/AML Examination Manual: What Compliance Officers …
By:Justin Muscolino
Sept. 19, 2024
10:00 AM PDT | 01:00 PM EDT
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
By:Bruce Lee
Sept. 20, 2024
10:00 AM PDT | 01:00 PM EDT
Employee or Independent Contractor – U.S DOL Announces 2024…
By:Margie Faulk
Sept. 20, 2024
10:00 AM PDT | 01:00 PM EDT
Human Factors Usability Studies Following ISO 62366 and FDA…
By:Edwin Waldbusser
Sept. 23, 2024
10:00 AM PDT | 01:00 PM EDT
Best Practices in Complaint Management for Regulatory Compl…
By:Jeff Kasoff
Sept. 23, 2024
12:00 PM PDT | 03:00 PM EDT
Ensuring Safe and Effective Pharmaceutical Products: A Comp…
By:Meredith Crabtree
Sept. 23, 2024
12:00 PM PDT | 03:00 PM EDT
Embracing Diversity and Inclusion in Talent Acquisition
By:Kyle Patrick Smith
Sept. 24, 2024
12:00 PM PDT | 03:00 PM EDT
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
By:Patrick Haggerty
Sept. 24, 2024
10:00 AM PDT | 01:00 PM EDT
Tattoos, hijabs, piercings, and pink hair: The challenges …
By:Dr. Susan Strauss
Sept. 24, 2024
10:00 AM PDT | 01:00 PM EDT
Gossip-Free: Leadership Techniques to Quell Office Chatter
By:Beverly Beuermann-King
Sept. 24, 2024
12:00 PM PDT | 03:00 PM EDT
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
By:Justin Muscolino
Sept. 24, 2024
10:00 AM PDT | 01:00 PM EDT
Understanding and Analyzing Financial Statements
By:Carl Young
Sept. 25, 2024
10:00 AM PDT | 01:00 PM EDT
Divorce, Adoption and Other Special Tax Topics
By:Jason Dinesen
Sept. 25, 2024
10:00 AM PDT | 01:00 PM EDT
Design History File (DHF), the Device Master Record (DMR) a…
By:Jose Ignacio Mora
Sept. 26, 2024
10:00 AM PDT | 01:00 PM EDT
Is Your Culture Working For or Against Your Success? If You…
By:Marcia Zidle
Sept. 26, 2024
12:00 PM PDT | 03:00 PM EDT
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
By:Bob McKenzie
Sept. 26, 2024
12:00 PM PDT | 03:00 PM EDT
Setting up Quality System for FDA Regulated Products: Tips …
By:Meena Chettiar
Sept. 26, 2024
12:00 PM PDT | 03:00 PM EDT
Marketing to Medicare or Medicaid Beneficiaries - What You …
By: William Mack Copeland
Sept. 27, 2024
12:00 PM PDT | 03:00 PM EDT
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
By:Dev Strischek
Sept. 27, 2024
10:00 AM PDT | 01:00 PM EDT
Sunshine Act Reporting - Clarification for Clinical Research
By:Danielle DeLucy
Sept. 30, 2024
12:00 PM PDT | 03:00 PM EDT
Documenting Misconduct that Will Stand Up in Court
By:Susan Fahey Desmond
Sept. 30, 2024
12:00 PM PDT | 03:00 PM EDT
Stress, Change And Team Resilience Through Humor: An Intera…
By:Mark Gorkin
Oct. 1, 2024
10:00 AM PDT | 01:00 PM EDT
Managing Toxic & Other Employees Who have Attitude Issues
By:Bob Verchota
Oct. 1, 2024
12:00 PM PDT | 03:00 PM EDT
FDA Regulation of Artificial Intelligence/ Machine Learning
By:Edwin Waldbusser
Oct. 1, 2024
10:00 AM PDT | 01:00 PM EDT
Pharma 4.0: Next Generation Technology Approach to GxP Prod…
By: Carolyn Troiano
Oct. 2, 2024
12:00 PM PDT | 03:00 PM EDT
Excel - Lists and Tables - A Beginner's Guide to Managing L…
By:Mike Thomas
Oct. 2, 2024
10:00 AM PDT | 01:00 PM EDT
Patient Gifts, Discounts and Freebies: What You Can and Can…
By:Joseph Wolfe
Oct. 3, 2024
10:00 AM PDT | 01:00 PM EDT