Stability Testing & Program Management Excellence
Part of Laboratory University
Stability testing is critical to the efficacy of drug substances. ICH, FDA and WHO stability guidance’s have been around for quite some time and are strictly enforced, however, industry still has challenges to overcome and seeks more direction. The time has never been more critical to evaluate your program and ensure your organization has an advanced, compliant processes that exceed the expectations of regulators.
Stability Leaders Showcase Best-In-Class Programs:
- Stability Chambers Selection, Validation, and Calibration
- Stone Cold – Biologics, Tissue, Cell and Gene Therapy Stability Practices
- Program Development, Implementation and Management
- Staples of and Best Practices in Applying Stability Statistics
- Elements of Sample Control-Compliance, Inventory, and Tracking
- How Much Does a Stability Study Cost? Developing a Stability Financial Budget
- Special Focus Sessions: LIMS – Statistics – Sample Handling – Chambers – Regulations – CROs
- Manufacturing and Shipping Challenges to Stability – Developing a Stability Shelf Life Budget
- Method Development and Specifications
