A company recently received the following observation regarding lab data: ….. Established laboratory control mechanisms […]
About GMP Trends
GMP Trends® was created to provide relevant, real-time, and unbiased information related to U.S. FDA inspections. We have a proprietary process by which we obtain immediate access to all FDA inspection information on a real-time basis. Over our 30 years of providing this information to our clients, we have seen our readership grow to thousands of subscribers across the globe.
Our mission is to provide our clients with the knowledge necessary to be compliant with FDA's most recent cGMP expectations thus enabling the production of the highest quality pharmaceutical and medical devices in the world.
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.
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.
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.
President and Chief Editor
The Bi-Monthly Trends Report
Our Bi-monthly GMP Trends Report gives our readers the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format.
According to the Code of Federal Regulations (21 CFR 211.192 Production Record Review), the failure […]