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

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

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.