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:

• Validation Sampling Plans course – How many samples do I need and how can I reduce this?
• Normality Testing and Transformations course – How do I handle nonnormal data?

Reference Documents

This course covers material found in the following reference documents:

DEVICES

• Code of Federal Regulation: Title 21, Subsection H, Part 820, Section 820.75.
• Federal Register – Preamble Vol. 61, No. 195, October 7, 1996.
• Global Harmonization Task Force (GHTF): “Quality Management Systems – Process Validation Guidance – Edition 2,” January 22, 2004.
  • See Methods and Tools for Process Validation appearing as Annex A of the guidance.
• Global Harmonization Task Force (GHTF): “Quality Management Systems – Process Validation Guidance – Edition 1,” June 29, 1999. (OBSOLETE)
• Food & Drug Administration (FDA): “Design Control Guidance for Medical Device Manufacturers,” March 1997.

DRUGS

• Food & Drug Administration (FDA): “Process Validation: General Principles and Practices,” January 2011.
• Process Validation A Lifecycle Approach, Grace E. McNally, FDA, May 6, 2011.
• Food & Drug Administration (FDA): “Guideline on General Principles of Process Validation,” May 1987. (OBSOLETE)