ICH-Q7
May 03 - 05, 2010
New Brunswick, NJ
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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
Mar 22 2010, New Brunswick, NJ
Analytical Methods Validation for FDA Compliance
Apr 19 2010, Amsterdam, The Netherlands
Documentation Management and Control
Mar 22 2010, Amsterdam, The Netherlands
Drug Product Stability and Shelf-Life
May 31 2010, Dublin, Ireland
Developing Specifications for Drug Substances (APIs) and Drug Products
Excipient GMPs
Granulation, Tabletting and Capsule Technology
Apr 19 2010, East Brunswick, NJ
Granulation, Tabletting and Capsule Technology
May 17 2010, Amsterdam, The Netherlands
Lyophilization Technology
Apr 07 2010, Burlingame, CA
Lyophilization Technology
May 31 2010, Amsterdam, The Netherlands
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