ICH-Q7
November 30 - December 02, 2009
Amsterdam, The Netherlands
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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 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 critically during the course.
Throughout the formal presentations participation by the
registrants is welcome and expected.
There are interactive exercises periodically spaced through
the first two days that allow registrants 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
registrants 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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