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
- Those who perform and manage stability programs
The live version of this recording took place on November 30, 2022
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
USP Approved Instructor
Steven Walfish
USP Consultant
M.S., Statistics, Rutgers University
MBA, Boston University
B.A., Statistics, University of Buffalo