Summary
Stability data form an important element of pharmaceutical regulatory submissions. This 3-day course will equip participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements. The course covers stability evaluations performed throughout the drug product life cycle, from product development to post-approval changes. Topics include fundamental chemical concepts, protocol design and the appropriateness of test methods for stability studies. The specific challenges posed by biological molecule stability are also covered. Each day includes a workshop session designed to reinforce key learning points.
Learning Objectives
- Key degradation mechanisms for drugs and biologics
- Protocol design, including bracketing and matrixing
- Establishing the suitability of analytical methods
- Considerations for global registration
- Justifying impurity limits
- Handling temperature/humidity excursions and anomalous results
- Designing stability studies to support post-approval change
Key Topics
- Drug degradation chemistry
- Regulatory guidance
- Registration in different climatic zones
- Stability chamber management
- Design and validation of test procedures
- Trending stability data – managing out-of-specification/out-of-trend results
- Data integrity
- Predictive stability
- Stability testing for biologics
- Impact of leachables on drug product stability
Who should attend?
Formulation Development Scientists, Process Development Personnel, Analytical Development Scientists, Quality Control Personnel, Stability Study Managers, Regulatory Affairs Specialists, Project Managers
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainer
Pharma & Biotech Stability Testing
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
