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Process Validation Principles (1-day)
Teaches the basic principles and steps in performing a process validation. Course is based on the GHTF (Global Harmonization Task Force) process validation guidance document and other applicable references. Designed for the medical device and pharmaceutical industries.
Further describes the statistical tools applicable to process validation and how to integrate them into the IQ-OQ-PQ phases of validation. The course topics include determining key inputs, determining worst-case conditions, selecting sample sizes, control plans, handling compensating adjustments, and much more. Upon completion of this course you will understand the general process for performing a process validation.
This course is designed for all individuals who are involved in process validation. This includes engineers, manufacturing and quality supervisors, and management. No statistical or mathematical background is required.
This course is frequently combined with the courses below to create a comprehensive 2.5 days of training on Process Validation:
This course covers material found in the following reference documents:
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Last modified: September 29, 2016