Statistical Concepts of Process Validation - 2017

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 validation
• Explain the FDA's approach as documented in Warning Letters
• Understand the ISO 13485:2016 requirements for process validation
• State the statistical model that links process input and process output
• Link sampling verification to the process model

Who Will Benefit:

• Quality Engineers
• Production Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners

Speaker 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: +1-800-447-9407
Email: [email protected]

Others Details

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