ICH guideline Q1A(R2), states that “the purpose of stability testing is to provide evidence on […]
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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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Line clearance is an integral part of every facility’s standard operating procedure in order to […]
According to the Code of Federal Regulations (21 CFR 211.42 Design and Construction Features), any […]