Stability profile is determined to be the critical quality attributes of drug substance and drug products. This course is intended to provide a basic to advanced level understanding on developing a stability program to support the expiration dating of pharmaceutical products. Content will focus on different aspects from development to commercial to understand the stability profile of drug substance and drug products. In addition, a thorough update of recent and emerging techniques used to establish the integrity, strength, quality and purity of drug products will be provided.
After completing this online course, the user will be able to:
Identify and discuss the current regulations globally required for a stability program to support expiration dating and use periods of drug products/API
Describe requirements for stability indicating methods
Monitor impurities in API and drug products
Identify/set stability specifications and change controls
Review, evaluate and discuss stability data
Create a stability report and CMC documents
This course is identified as a knowledge educational activity.
AAPS members, students, and academicians enjoy special
pricing. Previews of each of the lectures are available. Participants have
access to the course content for a 6 month period following purchase.
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