Current Good Manufacturing Practice (cGMP) for Purchasing
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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.