Q&A: CDER Official Offers Tips on GMP Inspections

For this article, MasterControl Inc., a leading software provider for life sciences and other regulated industries, interviews Kristen Evans, senior regulatory operations officer at the Office of Compliance of the FDA's Center for Drug Evaluation and Research (CDER).

Mr. Evans, whose FDA experience includes 17 years as an inspector, provides insights on issues commonly encountered by companies seeking FDA compliance. Cindy Fazzi, MasterControl copywriter and editor, conducted the interview by phone.

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