Statistical Concepts of Process Validation - 2017
- Start Date:
- Wednesday, 5 July, 2017
- End Date:
- Wednesday, 5 July, 2017 11:30am
- Health & Nutrition
Overview:Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation.Why should you Attend:If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material.
This presentation provides the background you need on the statistical approach to process validation.Areas Covered in the Session:Understand the QSR requirements for process validationExplain the FDA's approach as documented in Warning LettersUnderstand the ISO 13485:2016 requirements for process validationState the statistical model that links process input and process outputLink sampling verification to the process modelWho Will Benefit: Quality EngineersProduction ManagersProduction SupervisorsManufacturing EngineersProduction EngineersDesign EngineersProcess OwnersSpeaker Profile:Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management.
Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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