If FDA is inspecting your firm, one of the first places they will investigate is […]
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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
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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In our February 1st Issue, we highlight a specific 483-observation concerning rejected secondary packaging materials […]
In GMP Trends Issue Number 1152, we highlight observations related to manpower limitations and the […]