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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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May 22

Managing Safety Reporting for Advanced Therapies

May 24

Start Your Quality 4.0 Journey Today!: Achieve Quality and Operational Excellence Through Digital...

May 30

Cutting the Costs of Clinical Trial Subject Recruitment: Insights into Patient Outreach: Traditio...

May 31

FDA’s New Concept of Operations for Drug Inspections and Evaluations: What You Need to Do Today

Jun 5

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Jun 6

10 Sure-Fire Tips for Developing a Document Management System Any Investigator Would Love

Editor's Picks

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Additive Orthopedics Announces FDA Clearance of 3D Printed Bone Segments

The segments use a lattice structure to promote bone-in growth instead of older, more open types of structures.

FDA Reference Drug List Flags Companies That Hinder Generics

Some drugmakers refuse to sell samples of products using REMS with Elements to Assure Safe Use (ETASU), affecting distribution to generic competitors, or set conditions for sales that generics companies cannot meet.