Conduct a Gap Analysis of Your Process Validation Program

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  1. Plan for a Successful Gap Analysis
    • Define what is needed to complete the analysis
    • Develop the tools to conduct the Gap Analysis
    • Train your personnel to conduct the Gap Analysis
    • Define the scope of your Gap Analysis
  2. Determine the Gap in Your Process Validation Program
    • Define the ideal where you would like to be
    • Determine where you are
    • Define the Gap and what needs to be accomplished to bridge the Gap
    • Communicate with stakeholders
  3. Develop an Implementation Plan to Bridge the Gap
    • Documents to help define the plan
    • Use of a phased approach based on Risk
    • Schedule and cost of the various activities
    • Prepare a report and get approval

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Gamal Amer, Ph. D.

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.