FreeThink Technologies Webinar Series: cGMP ASAP

The Accelerated Stability Assessment Program (ASAP) enables very rapid determination of product shelf life. FreeThink’s laboratories conduct cGMP ASAP studies to meet clients’ needs with regulatory filings. FreeThink’s technical experts will discuss the approach employed.

What you will learn:

• Introduction to ASAP studies
• The work needed in advance of conducting the cGMP ASAP study
  – SOPs needed
  – Instrument and software qualification
  – Analytical method evaluation
  – ASAPprime® IQ/OQ/PQ
  – ASAP Study Design
  – Protocol preparation
• How to carry out the study itself and data analysis using ASAPprime® modeling
  – Study preparation and setup
  – Data collection and quantitation
  – Data entry into ASAPprime®
  – Modeling and outlier removal
  – Report generation from ASAPprime®
  – Managing the unexpected
• Finalizing the study

Introduction:
– Ken Waterman, Ph.D., President

Presenters:
– Dorothy Kopchik, Ph.D., GMP Systems Specialist
– Tom Morison, Quality Systems Manager

Moderator:
– Maria Krisch, Ph.D., Associate Director of Physical Sciences