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
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.