The Center for Professional Advancement, Amsterdam
1-2 October 2007
Who Should Attend:
This course has been designed for those who need to know the impact of the drug cGMPs on the purchasing function in the Pharmaceutical, Biopharmaceutical, Clinical and related industries. The material is of benefit to both technical and non-technical personnel who are directly or indirectly responsible for purchasing such items as:Raw Materials
Packaging Components
Printed matter and services used to produce drug products
Description:
Purchasing is a vital part of the operations used to produce pharmaceuticals for either commercial or R&D purposes including clinical supplies. Therefore, from an FDA viewpoint, the purchasing function must, where applicable, conform with the cGMPs for drugs. Some of this conformance forms part of the daily activities of purchasing such as the need to order only from approved suppliers. Other aspects are not so obvious, such as the need to know all aspects of the cGMPs when dealing with vendors or outsourcing situations. This course aims to familiarize purchasing personnel with the principles of cGMP. Following a discussion about the FDA and its attitude towards cGMP, the course provides a broad review of what constitutes the cGMPs, ranging from the FDA’s cGMP Regulations through to other FDA and industry association documents and also industry practices. The program then analyzes the FDA cGMP regulations in detail. How purchasing must understand and comply with cGMP will be discussed throughout by a faculty member who has wide experience with corporate management as well as the purchasing function.
|
|