Course Description
Learn about essential components for designing global stability programs for pharmaceutical products: regulations, operations, testing and investigations. Topics include cGMP, USP, FDA, ICH and WHO stability requirements for establishing expiration dating and label storage criteria; technical and regulatory aspects that may affect design cost-effectiveness and compliance; and stability indicating methods for monitoring product quality throughout its shelf life. Matrix and bracketing options to reduce testing, stability data evaluation and investigation of out-of-trend and out-of-specifications are also addressed. This course will also cover USP <1225> Validation of Compendial Procedures, USP <1226> Verification of Compendial Procedures.
Upon completion of this course, you will be able to:
- Identify the requirements of stability testing
- Describe the critical role of drug stability
- Interpret 21 CRF 211 as it relates to stability
- Explain the ICH process and Q1A
- Recognize the stability protocol for global submission
- Utilize stability-indicating test methods
- Interpret the ICH Q2 A/B on analytical method validation
- Identify critical steps of the stability process
- Identify benefits and drawbacks of bracketing and matrixing
- Evaluate stability data
- Determine corrective and preventative actions
Who Should Participate:
Scientists, chemists, QA/QC staff and those who perform and manage stability programs