Are You Ready for ICH Q11? Emerging Topics in the API Global Regulatory Environment (E07)
- Are you a chemist or engineer developing a manufacturing process for a new drug substance and do not know how to incorporate the principles of quality by design?
- Are you a regulatory manager and do not know how to compile a dossier submission for a new drug substance under the quality by design paradigm?
- Are you a quality assurance manger and do not know how to use continuous process verification as a tool for continuous improvement during the lifecycle of a drug substance?
This seminar will address all of these areas as well as other aspects of the enhanced science- and risk-based approach to drug substance development and manufacture as described in the new ICH guideline Q11 which is in the advanced stages of development.
Industry and Regulatory members of the ICH Q11 Expert Working Group who have authored the guideline will provide the background on the origins of Q11, the key concepts contained in the guideline and the progress made towards harmonization. These include drug substance critical quality attributes, establishment of a design space and identification of critical process parameters during the development of a manufacturing process.
Control strategy will be discussed including the designation and control of starting materials, as well as drug substance process validation/continuous verification and lifecycle management. Areas of the guidance that pertain specifically to biotechnological/biological products will be highlighted.
This seminar will build on the principles and tools described in “Addressing ICH - Robust Process Validation and Compliance Assurance Starts with Product Realization: Effectively Applying Quality by Design (PQLI®) (E02) taking place on 6-7 June at the same conference.
How You Will Benefit
At the conclusion of this seminar participants will be able to:
- Provide informed comments on the ICH Q11 guideline when it is published for public review
- Take the principles outlined in ICH Q11 and incorporate these into the development and lifecycle management of manufacturing processes for drug substances
- Adopt a quality by design submission to the Common Technical Document format
Who Should Attend
- Process Control Engineers
- Validation Engineers
- Quality Professionals
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom
This Session relates to the following Communities of Practice (COPs)
Science-Based Regulations Subcommittee of the API COP Community of Practice, API, Biotech, Good Control Laboratory Practices, Investigational Products, Operations Management, PAT, Product Process Development