Developing Specifications for Drug Substances (APIs) and Drug Products
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Who Should Attend
This course is intended for personnel from both Generic and
Research-based pharmaceutical industries including:-
Pharmacists
- Analytical and Synthetic Chemists from R&D
- Staff from Production Departments and from QA and QC
- Regulatory Affairs Personnel
- Pre-Clinical Scientists will benefit from the course by gaining a better understanding of the complexities of the drug development process and of the importance of setting specifications
Description
The course will present a review of the activities that will
occur in the process of setting specifications for APIs made
by synthesis or conventional fermentation. Critical
specification issues for drug substances and drug products
will be reviewed, specifically focusing on the interactions and
dialogue necessary between analytical and pharmaceutical/
chemical groups during the development of specifications.
Using practical examples, the importance of understanding
“real-life” constraints and regulatory requirements will be
highlighted across a wide variety of drug product
formulations. Strategies for Out-Of-Specification (OOS)
findings will be discussed. The course will review the latest
activities of ICH with respect to specifications for drug
substances and drug products. You will benefit in your job by
applying facts learned in this course. Increases in productivity
will result. An open and interactive environment is encouraged
throughout the course.