This continually updated course covers current 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:
- Purpose of stability studies and requirements for each type of study
- FDA and other health authority guidances and ICH stability guidelines
- Writing stability program SOPs
- Design of stability studies and stability protocol development
- Establishing successful stability data management systems
- Conducting and documenting OOT/OOS and deviation investigations
- Chemistry and testing considerations underlying the stability data
- Stability chamber selection, qualification and maintenance
- Stability sample management, cradle to grave
- Preparation for inspection of stability programs by regulatory agencies
- Case studies and lessons learned
Who Should Attend
This comprehensive course will be valuable to personnel evaluating stability of new chemical entities (NCEs), new molecular entities (NMEs), and formulations of brand and generic products. Course coverage includes small molecule, biologic and combination products for domestic and worldwide markets. 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 and establishing product specifications and commitments. This includes those whose job responsibilities require an in-depth knowledge of FDA guidances, regional and country-specific Health Authority regulations, as well as ICH and WHO requirements for stability programs, stability testing, and stability data analysis and presentation.
Please Note: This course primarily covers pharma products. Medical Devices are not addressed in this training program.
Providing a step-by-step foundation for establishing product shelf life through stability testing, this comprehensive training course outlines the issues and guidelines surrounding requirements for global compliance, such as the Americas, EMEA and ASEAN regions, plus country-specific health authorities like the FDA. Additionally, guidances and mandates from ICH and WHO will be discussed in detail. 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 country-specific and industry 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 health authority inspections of their stability testing laboratories, sample storage facilities, and stability programs. Example FDA 483s and other health authority observations are reviewed to better understand typical deficiencies and how to avoid them.