Pharmaceutical Stability (Live Webcast)

November 30, 2022 8:30 am
December 1, 2022 4:30 pm
Live Online Webcast

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 stabilityindicating
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-ofspecifications
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
  • Evaluate stability data
  • Determine corrective and preventative actions

Who Should Participate:

  • Scientists
  • Chemists
  • QA/QC staff
  • Those who perform and manage stability programs