FDA CDER Guidelines

FDA CDER Guidelines by a Senior Officer on GMP Inspections

In a telephone interview, Kristen Evans, a senior regulatory operations officer at the Office of Compliance in the FDA's Center for Drug Evaluation and Research ( FDA CDER ), provided insights on issues commonly encountered by companies seeking compliance with FDA CDER guidelines.

White Paper

How to Successfully Complete an FDA Inspection

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Free Resources

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White Paper: How to Successfully Complete an FDA Inspection White Paper: Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments White Paper: The Future of the FDA: Operating in an 'Electronic World' White Paper: FDA Inspections of Clinical Investigators: Are You Ready?
Toolkit: 11 Free Resources to Boost Your FDA Readiness
QuickStart Cards: 11.x MC QuickStart Card for Users-Readers

FDA CDER Guidelines that were Provided during Q&A Interview

This question-and-answer white paper provides FDA CDER guidelines and addresses the following:

The 12 most common problems pertaining to quality audit
Things that FDA investigators look for in terms of CAPA
What FDA investigators look for in terms of training control
How medical device companies can apply a 'risk-based' approach to quality management
What medical device firms ought to do prior to an FDA inspection

Role of FDA CDER Guidelines

As noted in the Q&A on FDA CDER Guidelines (which you can download above), the role of the FDA's CDER is to promote and protect public health by ensuring that all prescription and over-the-counter drugs sold in the U.S. are safe and effective. CDER's Office of Compliance monitors the quality of marketed drugs through inspections, product testing, surveillance, and other compliance programs.

The office of FDA CDER also develops standards for current good manufacturing practices (CGMP), clinical and good laboratory practices, and industry practices.

For More Information on FDA CDER Guidelines

For more information about GMP or FDA CDER guidelines, please feel free to contact a MasterControl representative.

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MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.

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