Process Validation Principles (1-day)

Instructor

Dr. Wayne A. Taylor

Course Objective

Teaches the basic principles and steps in performing a process validation.  The course is based on the GHTF (Global Harmonization Task Force) process validation guidance document and other applicable references.  It is designed for the medical device and pharmaceutical industries.

It describes the statistical tools applicable to process validation and how to integrate them into the IQ-OQ-PQ phases of validation using the Six Sigma Validation process.  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.

Primary Audience

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.

Course Outline

AM

  • What is Process Validation?
  • Master Validation Plan
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

PM

  • Process Validation Tools
  • Control Plan
  • Process Verification
  • Master Validation Report
  • Revalidation

Prerequisites

None.

Related Courses

This course is frequently combined with the courses below to create a comprehensive 2.5 days of training on Process Validation:

Reference Documents

This course covers material found in the following reference documents:

DEVICES

DRUGS