Course offering number:0806-105
Course ID:
840
Active Pharmaceutical Ingredients
2-4 June 2008
Amsterdam
Who Should Attend
This course is for individuals working in all phases of human
and veterinary Active Pharmaceutical Ingredients (API)
production and control including:-
Pilot and commercial production
- QA/QC
- Regulatory affairs
- Process development
- Engineering
- Management
The course models a GMP compliant API operation,
everyone’s role in achieving compliance, and penalties for
noncompliance. Government investigators who inspect API
operations are encouraged to attend.
Description
This course prepares attendees to meet the challenges
they face in this heavily regulated industry. It is vital for API
producers to ensure that GMP principles are applied to API
production and control, and to demonstrate knowledge of
FDA, ICH and other governmental and industry guidance
documents.
This course will provide guidance in the design, construction,
and validation of GMP pilot and production facilities. Examples
of facilities will be discussed. The selection, qualification, and
cleaning of equipment will be included with specific examples.
Process validation is of singular importance and validation
principles and their application will be demonstrated with
examples. Process development and technical transfer
reports will be described. The function of the quality unit
to establish and manage the systems required to maintain
compliance will be discussed. Throughout the program there
will be interactive class exercises. On the last day of the
course participants will receive instruction on managing an
FDA inspection followed by a workshop in which participants
prepare written responses to simulated FDA-483s (List of
Inspectional Observations) based on actual FDA
observations. The exercise will result in a valuable exchange
of information and approaches with your colleagues.
Other Courses of Interest
Developing Specifications for Drug Substances (APIs) and Drug Products
Drug Product Stability and Shelf-Life
May 31 2010, Dublin, Ireland
Excipient GMPs
Granulation, Tabletting and Capsule Technology
Apr 19 2010, East Brunswick, NJ
Granulation, Tabletting and Capsule Technology
May 17 2010, Amsterdam, The Netherlands
ICH-Q7
May 03 2010, New Brunswick, NJ
Microencapsulation and Particle Coating
Powder Mixing Technology
Jun 14 2010, Amsterdam, The Netherlands
Powders: Their Properties and Processing
Mar 22 2010, Boca Raton, FL
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