An essential component of good manufacturing practices, stability testing can be the make-or-break step in the manufacturing process. FDA guidelines determine which standards for shelf life a drug must meet, including humidity and temperature controls, but all testing must happen in a controlled environment for valid results.
The development and widespread adoption of stability test chambers has been a breakthrough for the pharmaceuticals industry, and a boon to those who work in developing and implementing stability programs as part of a good manufacturing practices process. As regulations for testing necessarily become more stringent, the need for stability test chambers is growing accordingly.
This growth is projected at a CAGR of 5.8% between now and 2027, forecasting an increase in both drug development and a tightening of regulations for the production of both prescription-based and over-the-counter medications.
As new technology is adopted and its adoption both spurs and allows for new regulation guidelines, how can pharmaceutical professionals keep up? Our Stability Programs for Determining Product Shelf Life course not only ensures that you understand today’s best practices, but that you’re also prepared for changes that are coming in the future. Being adaptable as FDA regulations change is one of the key characteristics that makes a successful good manufacturing practices professional.
Stability Programs for Determining Product Shelf Life course is available as a two-day session, covering stability testing program prerequisites, statistical approaches, how to prepare CTD and eCTD forms for submission to the FDA, and more. Students are encouraged to prepare questions for the instructor based on the real problems that they’re facing in the industry now. Every instructor at CfPIE is a former industry professional who understands the challenges faced by their students who work in the drug development pipeline.
If you would like to learn more about good manufacturing practices, this course is part of the (GMPCP) Current Good Manufacturing Practices (cGMP) Certified Professional™ certification track.
Source:
https://www.globenewswire.com/news-release/2019/04/01/1790756/0/en/Stability-Test-Chamber-Market-Expected-to-Witness-a-CAGR-of-5-8-over-2019-2027-FMI.html
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