FDA cited a firm for training records that failed to specify which SOP revision employees […]
Get in Touch
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
Join the thousands of professionals who rely on GMP Trends® to help them stay in compliance!
FDA cited a firm for failures pertaining to labeling integrity, inspection, and storage. The 483 […]
The most recent GMP Trends Report highlights a striking observation relating to a firm’s failure […]