Regulatory
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.
Select all the resources you’re interested in downloading
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
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 about GMP or FDA CDER guidelines, please feel free to contact a MasterControl representative.
To learn more about MasterControl's software systems, please contact a MasterControl representative.
