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