CDER

Senior Officer from CDER Offers Tips 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 ( CDER ), provided insights on issues commonly encountered by companies seeking FDA compliance.

Downloads:

	Q&A: CDER Offical Offers Tips on GMP Inspections
	White Paper: Change Control - Quality Improvements in FDA and ISO Environments
	White Paper: Does Your CAPA System Need a CAPA?
	White Paper: Automating Document Control Processes to Comply with FDA and ISO Requirements
	White Paper: Automating Training Processes to Comply with FDA and ISO Requirements
	White Paper: 21 CFR Part 11 - Risk of Non-compliance
	White Paper: FDA's Quality Systems Approach to Pharmaceutical CGMPs

Role of CDER

As noted the the Q&A, which you can download above, the purpose of 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 (including nontraditional drugs) through inspections, product testing, surveillance, and other compliance programs.

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