Process Validation Principles (1-day seminar)

Instructor

Dr. Wayne A. Taylor

Course Objective

Designed for the medical device industry, this in-depth course 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. The course is based on the Global Harmonization Task Force (GHTF) process validation guidance document but covers other applicable references. Upon completion of this course you will know how to perform a process validation.

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?
• Variables Sampling Plans and Normality course - How do I handle nonnormal data?

Intended 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.

Reference Documents

This course covers material found in the following reference documents:

• Code of Federal Regulation: Title 21, Subsection H, Part 820, Section 820.75.
• Global Harmonization Task Force (GHTF): “Quality Management Systems - Process Validation Guidance – Edition 2,” January 22, 2004. 
• Food & Drug Administration (FDA): “Guideline on General Principles of Process Validation,” May 1987.
• Federal Register - Preamble Vol. 61, No. 195, October 7, 1996.
• Food & Drug Administration (FDA): “Design Control Guidance for Medical Device Manufacturers,” March 1997.

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

Schedule

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Last modified: June 02, 2008