Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
WebcastFaculty
OVERVIEW
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device is organized by Compliance Global Inc. and would be held on Jun 21, 2017.
The target audience for this medical event for 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.
Learning Objectives :
This medical device process validation training 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 this Webinar :
• 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.
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.
Additional details will be posted as soon as they are available.
• 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.
Learning Objectives :
This medical device process validation training 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 this Webinar :
• 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.
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.
Additional details will be posted as soon as they are available.
SPECIALITIES
Healthcare Technology
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