Excipient GMPs
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is intended for chemical manufacturers
who want to learn about supplying excipients to the
industry and for those manufacturers already supplying
excipients that need to learn about excipient GMP
compliance. It is also intended for pharmaceutical
manufacturers that must assess the compliance of
their excipient suppliers to appropriate GMP
requirements.
Personnel in the following areas have found this course
beneficial:-
Quality Assurance
- Quality Control
- Regulatory Affairs
- Quality Audit
- New Business Development
Description
This course will cover the regulatory, quality, and
manufacturing issues involved in providing chemicals
for use as excipients (inactive ingredients) in the
manufacture of drug products.You will learn about the
regulation of chemicals sold for use as excipients by
the FDA, the expectations of the pharmaceutical
industry, and excipient quality system requirements
(GMP). There will also be topical information on current
issues facing the industry.