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    Our Editors and Advisory Team

    Experienced professionals with manufacturing, quality assurance and regulatory affairs expertise in pharmaceuticals and medical devices.

    Jamie is a private equity investor with operating experience leading teams in highly regulated industries including pharmaceuticals, medical devices, and aerospace.

    Jamie Schleck

    Investor and Adviser

    Denise Thompson is Manager of Operations for GMP Trends and brings years of experience in correspondence with the Food and Drug Administration.

    Denise Thompson

    Manager of Operations

    Dina Kisver has operating experience as Vice President of Quality for a manufacturer of active pharmaceutical ingredients. She holds an MS degree in Quality Assurance and Regulatory Affairs from Temple University.

    Dina Kisver

    President and Chief Editor

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    Second person verification is an essential part of GMP compliance. The job of the second […]

    Employee training is a vital part of any robust quality management plan.  GMP Trends Annual […]

    According to 21 CFR 820.30(g), as part of the design validation process, risk analysis must […]