Course offering number:1003-402
Course ID:
840
Active Pharmaceutical Ingredients
March 22-24, 2010
New Brunswick, NJ
Who Should Attend
This course is for individuals working in all phases of human
and veterinary Active Pharmaceutical Ingredients (API)
production including:
• Pilot and commercial production
• QA/QC
• Technical services
• Regulatory affairs
• Process development
• Validation
• Regulatory agency investigators
The presenters discuss requirements for a GMP compliant
API operation, everyone's role in achieving compliance and
penalties for noncompliance.
Description
This course prepares attendees to meet the challenges they
face in the heavily regulated pharmaceutical industry. API
manufacturers must ensure that GMP principles are applied to
API production and there is extensive focus on relevant
operational, control, and regulatory activities with specific
examples. This information is essential for successfully
meeting GMP requirements that are sometimes only
incompletely expressed by official regulatory guidance
documents including ICH Q7.
Some of the topics discussed are design, construction and
qualification of GMP production facilities; selection,
qualification and cleaning of equipment; process development
and technical transfer; validation principles and process
validation. Regulatory agency compliance oversight, and
duties of the quality unit to establish and manage systems
required to maintain compliance will be discussed. Throughout
the program there are interactive class exercises. On the last
day of the course, participants receive instructions 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
Mar 08 2010, New Brunswick, NJ
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
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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