The course will cover:
Recent regulatory changes affecting stability including
* The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing
* Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM)
* 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.
* ASAP - using short term high stress testing to get accurate predictions of shelf life with a high degree of confidence – Freethink Technologies’ ASAPprime®
* Low level impurities and their impact on product stability
* Manipulation of tablet internal pH to improve product stability
The course is designed for people working in:
* Analytical and Product Development
* Analytical 91AV
* Stability Testing
* Formulation Development
* Regulatory Affairs
* Pharmaceutical & Biopharmaceutical Production
* Quality Control and Quality Assurance
* Technical Operations
Course Programme
Day 1
Introductions
* Quality by Design and the ICH updates QQ7, Q8, Q9, Q10 and Q11 - implications for stability testing
* Changes to EU GMP guidance with implications for stability - Chapter 1 and Annexes
* Product Quality Review and the interpretation of stability data
Delegate workshop - reviewing delegate-presented problems
DAY 2
* Low level impurities and their impact on drug product stability.
* ASAP - using short term, high stress testing to get accurate predictions of drug substance and drug product shelf life with high confidence using ASAPprime® software
* Bracketing and matrixing and accurate data interpretation, using the “Stability” software package from Arlenda
* Manipulation of tablet internal pH to improve product stability
* In Silico prediction of drug degradation pathways using the Zeneth software systems
* Action Planning and Final Q&A. Delegates are encouraged to send data for analysis prior to the course
Additional Resources
Online access to comprehensive publications including all relevant guidance will be provided as well as colour copies of all presentations and case studies.
Recent regulatory changes affecting stability including
* The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing
* Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM)
* 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.
* ASAP - using short term high stress testing to get accurate predictions of shelf life with a high degree of confidence – Freethink Technologies’ ASAPprime®
* Low level impurities and their impact on product stability
* Manipulation of tablet internal pH to improve product stability
The course is designed for people working in:
* Analytical and Product Development
* Analytical 91AV
* Stability Testing
* Formulation Development
* Regulatory Affairs
* Pharmaceutical & Biopharmaceutical Production
* Quality Control and Quality Assurance
* Technical Operations
Course Programme
Day 1
Introductions
* Quality by Design and the ICH updates QQ7, Q8, Q9, Q10 and Q11 - implications for stability testing
* Changes to EU GMP guidance with implications for stability - Chapter 1 and Annexes
* Product Quality Review and the interpretation of stability data
Delegate workshop - reviewing delegate-presented problems
DAY 2
* Low level impurities and their impact on drug product stability.
* ASAP - using short term, high stress testing to get accurate predictions of drug substance and drug product shelf life with high confidence using ASAPprime® software
* Bracketing and matrixing and accurate data interpretation, using the “Stability” software package from Arlenda
* Manipulation of tablet internal pH to improve product stability
* In Silico prediction of drug degradation pathways using the Zeneth software systems
* Action Planning and Final Q&A. Delegates are encouraged to send data for analysis prior to the course
Additional Resources
Online access to comprehensive publications including all relevant guidance will be provided as well as colour copies of all presentations and case studies.
