Forced Degradation and Stability Testing of Biopharmaceuticals Course Outline

Who Should Attend: This is a recommended training course. It is designed for anyone who works at a biopharmaceutical firm who wants to understand what is required in setting up a stability program, establishing expiration dates and other regulatory requirements related to stability. This course is recommended for analytical and formulation scientists as well as quality and regulatory professionals responsible for Chemistry, Manufacturing and Controls (CMC).

Click on the titles below to learn more about each session. Sign up anytime and receive links to recordings of any individual sessions or all four sessions. Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course. Each live session is interactive: Login, listen, learn and ask questions!

Overview of Stability Testing

  • Instructor: Dr. Patricia W. Cash
  • Format: Live session in Early 2025. Recording available within two weeks after live session.
  • Content:
    • Relationships among data, information, and models
    • What is the main purpose of stability studies?
    • How do you develop of stable formulations?

Forced Degradation Studies

  • Instructor: Dr. Patricia W. Cash
  • Format: Live session in Early 2025. Recording available within two weeks after live session.
  • Content:
    • Why do forced degradation studies?
    • What are common degradation pathways?
    • How do I choose analytical tests to measure degradation?
    • What are phase-appropriate forced degradation studies

Phase-Appropriate Formal Stability Studies

  • Instructor: Dr. Patricia W. Cash
  • Format: Live session in Early 2025. Recording available within two weeks after live session.
  • Content:
    • What are the regulations regarding stability?
    • How do I choose which assays to use in my formal stability?
    • How much data is needed at Phase 1?
    • How much data is needed at Phase 3?
    • Are there additional studies required at Phase 3?

Other types of Stability/Forced Degradation Studies

  • Instructor: Dr. Patricia W. Cash
  • Format: Live session in Early 2025. Recording available within two weeks after live session.
  • Content:
    • Early studies to understand your molecule
    • Distinguish between product related substances and product relate impurities
    • Demonstrate comparability
    • Analytical method validation
    • Justify temperature excursions

COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant.  For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.