Center for Professional Innovation & Education, Inc., King of Prussia, PA
Dec. 5 & 6, 2013
This continually updated course covers current FDA regulatory requirements and ICH guidelines for designing stability programs from the early stages of product development all the way to approval. Among the topics to be discussed will be: FDA’s guidelines and ICH regulations for stability testing
Writing study protocols and SOPs
Designing and validating stability indicating analytical test methods
Establishing successful stability data management systems
Conducting and documenting OOS investigations and deviations
Preparation for inspection of stability programs as part of the approval process by regulatory agencies
Additionally, case studies will be covered for small molecule NCEs, large molecule NMEs, polymer therapeutics and photodynamic chemotherapy.
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