Program Overview
This program introduces participants to the fundamentals of Stability Operations across drugs, biologics, and medical devices. The course covers key concepts, global regulatory frameworks, and critical stability stages, including pre-formulation, development, registration, and post-approval phases. With real-life case studies, interactive exercises, and deep-domain insights, the program equips participants with the knowledge and tools to address stability-related challenges, optimize protocols, and ensure compliance with industry standards. Delivered by a seasoned industry expert, the course bridges theoretical learning with actionable, problem-solving skills.
Features
- Understand the fundamentals of stability operations, including key terminologies and processes.
- Navigate global regulatory guidelines (ICH, FDA, EMA) and ensure compliance in stability testing.
- Identify and resolve stability challenges across different product lifecycle stages.
- Develop and optimize stability-related SOPs to improve operational efficiency.
Target audiences
- Professionals in pharmaceutical, biotech, and medical device industries
- R&D team
- QA/QC team
- Regulatory Affairs and Production teams
Instructor
