Program Overview
This advanced training program provides an in-depth understanding of stability operations for drugs, biologics, and medical devices. The course covers key topics such as managing stability metrics, handling global harmonization challenges, risk management, dealing with stability-related dilemmas, and preparing for stability audits. Participants will explore how to manage stability studies, control excursions, and address issues like outsourcing and disaster planning. Delivered by an industry expert with 25+ years of experience, the program combines conceptual understanding with practical examples, simulations, and interactive exercises, ensuring participants can apply these insights to resolve real-world stability challenges.
Features
- Understand and apply advanced stability metrics and global harmonization strategies.
- Manage and resolve complex stability challenges such as OOT, OOS, and OOL results.
- Develop effective risk management plans for stability operations, including outsourcing and disaster recovery.
- Be equipped to prepare for and successfully navigate stability audits and regulatory inspections.
Target audiences
- Professionals involved in stability testing, quality assurance, and regulatory affairs for pharmaceuticals, biologics, and medical devices.
Instructor
