How to Satisfy the FDA

A new training course designed to steer pharmaceutical manufacturers through the tricky process of US FDA approval has been launched by RSSL Pharma Training. "FDA Pharmaceutical Regulation & Inspection" will be held for the first time at RSSL's Pharmaceutical Training Centre in Reading on November 11th 2004.

RSSL Pharma's Training Manager, Dominic Parry describes it as, "A course for anybody who would benefit from an increased knowledge of the regulatory requirements of the USA. One of the main concerns regarding current Good Manufacturing Practice (cGMP) in the USA is the understanding and interpretation of the word "current". Pharmaceutical companies wishing to supply this massive market must therefore fully understand the regulations and systems in place concerning the manufacture and testing of pharmaceutical products for sale in the United States."

This course will provide delegates with invaluable insight into how the system works in the USA and covers the structure, role and authority of the FDA and will explain how its inspection system functions. The structure and legal status of both the Code of Federal Regulations (Parts 210 and 211) and the US Pharmacopeia will be detailed. In addition, the course will introduce the various sources of information available that companies must use to ensure that they are complying with the latest cGMP trends, including current issues and recent inspection findings.