This course has been updated to reflect the recent changes in the pharmaceutical stability testing world.
The new course content will provide a comprehensive update on current trends which offer substantial potential savings in time and resources in a traditionally costly testing area. It will include opportunities for review of specific participant problems
The course will cover:
Recent regulatory changes affecting stability including:
鈥� The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing
鈥� Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM)
鈥� Product Quality Reviews and the interpretation of stability data.
Recent scientific developments with implications for stability, with a particular focus on cost reduction, shortening of development timelines, and improvements on existing interpretation systems.
鈥� ASAP - using short term high stress testing to get accurate predictions of shelf life with a high degree of confidence 鈥� Freethink Technologies' ASAPprime庐
鈥� Low level impurities and their impact on product stability
鈥� Manipulation of tablet internal pH to improve product stability
The course is designed for people working in:
鈥� Analytical and Product Development
鈥� Analytical Chemistry
鈥� Stability Testing
鈥� Formulation Development
鈥� Regulatory Affairs
鈥� Pharmaceutical & Biopharmaceutical Production
鈥� Quality Control and Quality Assurance
鈥� Technical Operations
The new course content will provide a comprehensive update on current trends which offer substantial potential savings in time and resources in a traditionally costly testing area. It will include opportunities for review of specific participant problems
The course will cover:
Recent regulatory changes affecting stability including:
鈥� The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing
鈥� Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM)
鈥� Product Quality Reviews and the interpretation of stability data.
Recent scientific developments with implications for stability, with a particular focus on cost reduction, shortening of development timelines, and improvements on existing interpretation systems.
鈥� ASAP - using short term high stress testing to get accurate predictions of shelf life with a high degree of confidence 鈥� Freethink Technologies' ASAPprime庐
鈥� Low level impurities and their impact on product stability
鈥� Manipulation of tablet internal pH to improve product stability
The course is designed for people working in:
鈥� Analytical and Product Development
鈥� Analytical Chemistry
鈥� Stability Testing
鈥� Formulation Development
鈥� Regulatory Affairs
鈥� Pharmaceutical & Biopharmaceutical Production
鈥� Quality Control and Quality Assurance
鈥� Technical Operations
