A Step-by-Step Approach to Process Validation

Process validation is required by process control regulations for both drugs and medical devices. This course outlines the important tasks performed during each phase of the validation life cycle, as well as the information that should (and should not) be included in validation documents and why processes must be monitored once they are validated. Topics in this course include: Validation Life Cycle, Process Design, Process Qualification including IQ, OQ, PQ, Product Process Qualification, Change Control, and Documentation. After completing this course, you will be able to recognize the validation life cycle, process validation steps, and how the EU regulations differ from FDA requirements. You will also be able to identify validation principles that pertain to the medical device industry.

Recognize the definition of process validation as it relates to pharmaceutical products and medical devices. Identify the steps involved in process validation. Identify how the process differs between FDA and EU regulatory agencies.