Webinar On "Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device"

Event Details

Time: March 6, 2018 from 1pm to 2:30pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Website or Map: http://bit.ly/2GMcwwV
Phone: 1-844-216-5230
Event Type: online, /, webinar
Organized By: Sam Miller
Latest Activity: Feb 27, 2018

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Event Description

Description :

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.

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.

Why

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
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

About Speaker:

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.