ICH-Q7
Label
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Who Should Attend
This comprehensive course has been designed for individuals
whose responsibilities require an understanding of the quality
and regulatory aspects of Active Pharmaceutical Ingredient
(API) production for both commercial and clinical trial material.
Personnel in the following fields should attend:
• QA/QC
• Regulatory Affairs
• Commercial Production
• Process Development
• Pilot-Plant Operations
• Auditing
• Validation
• Management
Regulatory agency investigators who inspect API operations
and facilities are encouraged to attend. Registrants will benefit
from individual and group discussion of compliance issues
related to worldwide API production in locally regulated
environments.
Description
It is essential that API production facilities operating under
local regulatory authorities in different regions consistently
produce the same API that meets the quality attributes and
characteristics it is intended to have. An Expert Working
Group developed the ICH-Q7 document as a single standard
that all suppliers should apply to production of APIs used in
human products manufactured in any of the ICH signatory
regions. This course also includes sections on APIs produced
by cell culture/fermentation and on APIs used in clinical trials.
The course will provide historical insight and specific
interpretation of the requirements in the Q7 document along
with principles espoused in the draft ICH Q11 document.
The Q7 document addresses all aspects of API production in
19 sections and each of these sections will be critically
examined in detail during the course. There are also two
group discussions to clarify individual issues and exchange
information among colleagues. Also included is a workshop in
which registrants are asked to apply what they have learned
to resolve issues in test cases based on actual FDA-483
observations.
Other Courses of Interest
Active Pharmaceutical Ingredients
May 21 2012, New Brunswick, NJ
Active Pharmaceutical Ingredients
Jun 27 2012, Amsterdam, The Netherlands
Analytical Methods Validation for FDA Compliance
Mar 07 2012, Burlingame, CA
Documentation Management and Control
Mar 05 2012, New Brunswick, NJ
Documentation Management and Control
Jun 07 2012, Amsterdam, The Netherlands
Drug Product Stability and Shelf-Life
Mar 05 2012, New Brunswick, NJ
Drug Product Stability and Shelf-Life
May 30 2012, Amsterdam, The Netherlands
Developing Specifications for Drug Substances and Drug Products
May 07 2012, Burlingame, CA
Excipient GMPs
Granulation, Tabletting and Capsule Technology
Apr 23 2012, New Brunswick, NJ
Granulation, Tabletting and Capsule Technology
May 07 2012, Amsterdam, The Netherlands
Lyophilization Technology
Mar 12 2012, Amsterdam, The Netherlands
Lyophilization Technology
Apr 23 2012, New Brunswick, NJ
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