$150.00

Statistical Concepts of Process Validation – 2017

Statistical Concepts of Process Validation

Description

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: support@compliance4All.com

Ad Reference ID: 933591957c94b800

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