Process Validation

Course Outline In the pressure to get products to market, process validation is very often rushed through or inadequately completed. It’s partly a question of time, but also that this area is not as well understood as it should be. Staff often do not fully grasp how to show that a process has been successfully validated, for instance, or the differences between IQ, OQ and PQ. And many professionals tell us they are daunted by the statistical processes and interpretation involved. Under EN ISO 13485 and 21 CFR Part 820, all critical processes must be validated when the process cannot be successfully verified, so it’s important to keep on top of this subject. However, many professionals aren’t 100% clear on what needs to be documented to show that a process has been successfully validated. This course helps you get on top of the subject – explaining all the requirements and steps involved in validating a process; getting you up to scratch with the regulatory requirements; and providing you with all the tools to understand and interpret the statistical data.

Topics covered include

  • What is process validation?
  • Validation vs Verification
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Capability Studies
  • Statistical methods & data interpretation
  • Maintaining a state of validation

Outcomes

  • Understanding of the regulatory requirements
  • Understanding the processes involved in validating a manufacturing process
  • An appreciation for the statistical methods involved
  • How to interpret your data into a meaningful and useful output
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