Complying with FDA/ICH Requirements for Stability Testing
Training Overview
Improve Your Ability to:-
Comply with ICH and FDA stability testing requirements to maintain regulatory compliance
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Establish a standard stability protocol and develop appropriate strategies for each phase of pharmaceutical development in order to streamline processes
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Investigate OOS and OOT stability results to ensure product integrity
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Determine when and how to utilize bracketing and matrixing designs to effectively and efficiently apply resources
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Ensure proper documentation and develop stability section of CMC submissions to avoid costly approval delays
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Validate and design stability test methods, including evaluation of forced degradation studies, to generate meaningful data
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Develop effective SOPs for stability testing to ensure initial, ongoing, and regulatory staff training
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Build the necessary infrastructure to support an effective stability program
PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive 14 hours (1.4 CEUs) of continuing education credit for full participation. ACPE # 326-000-06-002-L04, Initial release: 10/2006.
Booking Options
Booking Options:
- Register online or Call Customer Service - Tel: (866) 647-0921 or email register@pti-international.com
- Group Discounts (3 or more people for this course) - Call Michael Roche at (646) 895-7408 or email mroche@pti-international.com
- Bring this Course to Your Facility (10 or more people or further customization) - Call (800) 303-8194 or email OnSiteSolutions@pti-international.com