COURSE DESCRIPTION
OVERVIEW
Stability testing is mandatory as part of cGMP to demonstrate a pharmaceutical product meets its acceptance criteria throughout its shelf life. A sustainable stability program in compliance with current regulations is therefore critical to development of new pharmaceutical products. ICH Guideline Q1A (R2) contains harmonized expectations for global stability submission. Although sometimes confusing and contradictory, FDA and ICH mandates must be considered in tandem to gain market approval
The objective of this interactive 90-minute online course is to provide you with an overview to establish an effective and compliant stability program for pharmaceuticals and biopharmaceuticals. Discussion will include a thorough review of US FDA cGMP regulations/ICH Stability guidelines, development stability testing protocol supporting global markets, and strategies to minimize redundant testing for resource saving.
LEARNING OBJECTIVES
By attending this course, you will learn:
- How to interpret FDA cGMP regulatory requirements for stability testing
- The role of the Stability Program during the drug development process
- Essential activities for Drug Product and Drug Substance/API stability programs
- Impact and proper use of ICH Guidelines in Stability Programs
- How to review FDA Warning Letters and 483s to enhance and maintain compliance
- How to keep your stability knowledge up to date
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