Excipient GMPs
This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.
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 and dietary
supplement manufacturers that must assess the
compliance of their excipient suppliers to appropriate
GMP requirements.br>
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, including requirements
for pharmaceutical excipients in Europe, Japan and
China. 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.
Other Courses of Interest
Active Pharmaceutical Ingredients
Apr 27 2009, New Brunswick, NJ
Granulation, Tabletting and Capsule Technology
Dec 08 2008, New Brunswick, NJ
Granulation, Tabletting and Capsule Technology
Mar 23 2009, Boca Raton, FL
Microencapsulation and Particle Coating
Feb 09 2009, New Brunswick, NJ
Powder Mixing Technology
Powders: Their Properties and Processing
Related Industries