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Course ID:
2091

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ICH-Q7
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Who Should Attend
This course is for individuals working in all phases of human and veterinary Active Pharmaceutical Ingredient (API) production and control including:

  • QA/QC
  • Pilot and Commercial Production
  • Auditing
  • Engineering
  • Validation
  • Technical Services
  • Regulatory Affairs
  • Process Development

Corporate managers benefit from opportunities the course offers for individual and group discussion of compliance issues. Regulatory Agency Investigators are encouraged to attend.

Description
This course will prepare you to meet the varied challenges now facing the global active pharmaceutical ingredient industry. It is important that API production facilities operating under different national and international regulatory authorities not be required to meet diverse standards. For this reason an Expert Working Group in ICH developed the ICH-Q7 document as a single standard that all suppliers must apply to production of APIs used in human drug products manufactured in any of the ICH signatory regions.

This course will provide historical insight into the development of the Q7 document and specific interpretation of requirements in the document. The Q7 document addresses all aspects of API production in 19 sections. Each of these sections will be examined in detail during the course. Throughout the formal presentations participation by the attendees is welcome.

There are interactive exercises periodically spaced through the first two days that allow attendees to analyze real life situations that occur in typical operations. These afford an opportunity to exchange information and approaches with colleagues. The final activity is a workshop in which attendees are asked to apply what they have learned to resolve issues in test cases.

Other Courses of Interest

Active Pharmaceutical Ingredients

Analytical Methods Validation for FDA Compliance
Sep 13 2010
, Burlingame, CA

Analytical Methods Validation for FDA Compliance
Oct 25 2010
, Amsterdam, The Netherlands

Documentation Management and Control
Sep 27 2010
, East Brunswick, NJ

Drug Product Stability and Shelf-Life
Dec 13 2010
, Amsterdam, The Netherlands

Developing Specifications for Drug Substances (APIs) and Drug Products

Excipient GMPs

Granulation, Tabletting and Capsule Technology

Lyophilization Technology
Oct 12 2010
, New Brunswick, NJ


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