The Center for Professional Innovation & Education, King of Prussia, PA
April 14 & 15, 2011
Who Should Attend This comprehensive course will be valuable to personnel evaluating stability of new chemical entities (NCEs) and new molecular entities (NMEs). Additionally, this course will be of great benefit to those in research and development, manufacturing, quality assurance, the quality control laboratory and regulatory affairs who are involved in conducting, supervising, or managing stability testing. This includes those whose job responsibilities require an in-depth knowledge of the FDA guidelines and ICH regulations as applied to establishing stability programs and conducting stability testing.
Learning Objectives Providing a step-by-step foundation for establishing product shelf life through stability testing, this comprehensive training course outlines the issues and guidelines surrounding FDA and ICH regulatory requirements. Specifically, this course will focus on establishing a successful stability program through in-depth discussions on writing and revising stability protocols, stability sample management, stability indicating assays, out of specification (OOS) results, and deviations. Practical techniques are reviewed to improve the integrity and predictability of stability data and ensure that test results comply with FDA and ICH requirements. By the end of the two-day course, attendees will gain the skill set necessary to interpret regulatory guidelines, design compliant stability programs, and effectively prepare submission-ready documents for FDA inspections of their stability testing laboratories and sample storage facilities. Sample 483s are reviewed to better understand typical deficiencies and how to avoid them.
Course Description
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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