New and important techniques in stability testing are facilitating product development using the Quality by Design approach. Using these it is possible to develop products more quickly and reliably, through improved methods of shelf life prediction and excipient testing. New stability testing protocols using the published ASAP method from Pfizer can generate information quickly and reliably. The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing in a highly interactive, relaxed environment:
• Why is stability testing required for product registration and GMP purposes?
• What are the requirements for Clinical Trials, new, and existing products?
• How can stability testing be applied during product development to shorten development times as well as improve product quality
• Stability testing outsourcing - successful management and execution
It will include:
• A comprehensive review of ICH stability testing guidance ICH Q1A
• Pitfalls in stability testing. Outsourcing—costs and benefits
• New approaches to stability testing including ASAP and the role of peroxides in product stability
• Stability Testing and QbD
• Workshops for attendees to present and discuss their own stability testing issues with the group
• Why is stability testing required for product registration and GMP purposes?
• What are the requirements for Clinical Trials, new, and existing products?
• How can stability testing be applied during product development to shorten development times as well as improve product quality
• Stability testing outsourcing - successful management and execution
It will include:
• A comprehensive review of ICH stability testing guidance ICH Q1A
• Pitfalls in stability testing. Outsourcing—costs and benefits
• New approaches to stability testing including ASAP and the role of peroxides in product stability
• Stability Testing and QbD
• Workshops for attendees to present and discuss their own stability testing issues with the group
