Process Validation and Change Control

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This web-seminar presents an overview of process validation and change control as they pertain to pharmaceuticals manufacturing.  We will review the general process validation approach, define what is meant by change control, its importance, and discuss what change control entails.


  1. Process Validation and the Validation Life Cycle
    • FDA Guidance on Process Validation and the life cycle approach
    • What is a validated or qualified state?
    • The role of Change Control in maintaining the qualified state
  2. Change Control and its Importance
    • Why Change Control?
    • The need for a change control system
    • The importance of change control
    • Change control and its importance in maintaining the qualified state
  3. Change Control Procedure and Post Change Monitoring
    • What a change control procedure may look like
    • Types of changes one may encounter and how to deal with them
    • Post change monitoring and its importance


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Gamal Amer

Principal, Premier Compliance Services, Inc.

Dr. Amer, a chemical engineer by training, has 40 years-experience in the pharmaceutical and related industries. He has held senior management positions with leading pharmaceutical, consumer products, and engineering consulting companies. His experience includes comprehensive process design in bulk pharmaceutical chemicals manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing, and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation.