Test Method Validation to Verify the Performance of a Medical Device
April 4, 2019 - Fremont CA USNetzealous LLC DBA - Compliance4All
compliance4all14@gmail.com
Phone:18004479407
Fax:302-288-6884
Overview: 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. 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. Areas Covered in the Session: When should Methods be Validated? Qualification vs Validation Types of Test Method Validations How to perform successful test method validations Who Will Benefit: Manufacturing Engineers Regulatory Affairs Teams Quality Assurance & Quality Control Teams Operations Teams Document Control Speaker Profile: Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, Jose 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. Event Fee: One Dial-in One Attendee Price: US $150.00 Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: compliance4all14@gmail.com