Developing Specifications for Drug Substances and Drug Products
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Who Should Attend
This course is intended for those who want to improve their
understanding of the overall process of developing
specifications for drug substance and drug products from
generic, OTC and research-based pharmaceutical industries.
The course includes both basic and advanced level topics of
interest to:
• Pharmacists
• Analytical and Pharmaceutical Chemists
• Staff from Chemical Production Departments
• QA and QC Professionals
• Regulatory Affairs Personnel
• Pre-Clinical Scientists
Description
This 2-day comprehensive course provides a broad overview
of the process of establishing specifications through various
development stages for drug products and drug substances
made by synthesis or by conventional fermentation. The
course focuses on the ICH approach for global harmonization.
Using practical examples, the importance of understanding
“real-life” constraints and regulatory requirements will be
highlighted. Attendees will have the opportunity to participate
in a hand-on-workshop to practice specification writing skills.
The latest activities of the ICH and pharmacopeial
harmonization relevant to setting specifications for drug
substances and drug products are reviewed. Strategies for
addressing Out-Of-Specification (OOS) findings will also be
discussed. There will be opportunities to meet with the
instructors and network with course participants. An open
and interactive learning environment is encouraged
throughout the course.
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
CMC Submissions in CTD Format
May 17 2012, New Brunswick, NJ
Drug Product Stability and Shelf-Life
Mar 05 2012, New Brunswick, NJ
Drug Product Stability and Shelf-Life
May 30 2012, Amsterdam, The Netherlands
ICH-Q7
Mar 19 2012, New Brunswick, NJ
ICH-Q7
Jun 25 2012, Amsterdam, The Netherlands
INDs/NDAs/CTDs
Orphan Drug Application and Submission
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