To explore how to design efficient stability protocols that can be applied globally and with reduced testing offering large cost savings.
Areas Covered in the Session
- Global storage conditions
- Basic protocol designs
- Advanced protocol designs
- Bracketed stability designs
- Matrixed stability designs
- Understand the storage conditions required globally
- Know how to choose the long term storage condition
- Understand the principles behind reduced stability testing
- Appreciate the benefits of reduced testing
- Be able to design bracketed and matrixed stability studies
- Be able to appreciate the risks involved in reduced testing
- Understand how to judge an appropriate reduction in testing
Who Will Benefit
- Analytical Scientists involved in Stability Testing
- Regulatory Affairs Scientists
- Qualified Persons
- Formulation Scientists involved with Stability Studies
Dr. Raymond Munden has over 30 years’ experience in pharmaceutical research and development and was formerly Head, Analytical Services Europe for GlaxoSmithKline. He has led project teams that developed many new chemical entities and their pharmaceutical products that were successfully taken to market. Dr. Munden is an expert in stability protocol design and testing, stability storage facilities, experimental design and degradation chemistry. He is now a consultant for all aspects of pharmaceutical development.
Have fronted GLP and GMP inspections by regulatory inspectors and carried out numerous audits of pharmaceutical development laboratories and contract laboratories. Skilled presenter who has run many training courses internationally.
Specialties: Knowledgeable about all aspects of pharmaceutical development, especially Pharmaceutical Analysis and an acknowledged expert in validation and in stability testing.