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 Should You Attend:
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.
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 provides guidance on 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 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.
Areas Covered in the Webinar:
Who Will Benefit:
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 controlled documents and a template for strategic deployment.
Jose 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.
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
6201 America Center Drive Suite 240, San Jose, CA 95002, USA
PAYMENT METHOD: 100% Secure Transaction