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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


- Ken Waterman, Ph.D., President

- Dorothy Kopchik, Ph.D., GMP Systems Specialist
- Tom Morison, Quality Systems Manager

- Maria Krisch, Ph.D., Associate Director of Physical Sciences


May 19, 2020 10:00 AM in Eastern Time (US and Canada)

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