Quality Training

Introduction to Validation

Objectives

This is a foundation course - Introduction to Validation for medical technology industry.

Content includes

Understand the context of process validation within the Quality Management System

• Be familiar with the definitions and terminology of validation
• Know about the lifecycle of validation.
• Appreciate the quality regulations pertaining to the Medical Device industry
• Be familiar with the documents containing quality regulations
• Consider what happens if validation goes wrong
• Appreciate their own role in the product they validate, make or support
• Understand the role of process control in maintaining a validated state
• Consider the difference between validation and verification
• Appreciate the documents and records required to support process validation.
• Understand basic concepts of supporting regulations such as Part 11 compliance

Who should attend

Personnel who require an introduction to process validation

Upcoming dates:

No training dates available at the moment.