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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.

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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Events

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Aug 22

Corporate Compliance & Liability: What Medical Product Professionals Need to Know

Aug 23

What CDER Can and Can’t Do: An Inside Look from an Agency Official

Aug 23

Clinical Trials in the Precision Medicine Era: New Techniques, New Complexity

Sep 10

Mastering EU Medical Device Regulation

Sep 12

Top Tips for Establishing Device Supplier Quality Metrics: Develop a World-Class Program to Boost…

Sep 17

Medical Device Quality & Compliance Institute 2018: Quality Systems and Design Control Training

Editor's Picks

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CoreLink’s 3D Anterior Lumbar Approved by FDA

The implant allows for better imaging by minimizing material density.

Endo Resumes Lawsuit Against FDA Over Bulk Drug Compounding Decree

The company claimed the agency’s handling of bulk compounding laws violates the 2013 Drug Quality and Security Act, treating the laws as non-binding guidance rather than a legal mandate.