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Webinar: Commercial Reality and Lifecycle Management of ASDs
This is the third session of a three-part webinar series on Amorphous Solid Dispersions by Spray Drying: From Early Formulation to Commercial Lifecycle Management.
Thursday, April 20th
Registrations to the webinar are subject to approval.
Watch On-demand.
Gated content. Registration is required.
| Featured Hovione experts in this webinar | |
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| Inês Salsinha, M.Sc. Quality Assurance Specialist Site QA |
Tiago Porfirio, Ph.D. R&D Manager, Particle Engineering Corporate Technical Services |
After presenting Hovione’s formulation screening and scale-up methodologies for amorphous solid dispersions (ASDs) by spray drying, the webinar series will conclude by discussing the link between development, process validation and lifecycle management.
Inês Salsinha and Tiago Porfirio will explain how to perform a critical and extensive evaluation of potential failure modes, how to carry out risk assessment and how to define criticality to enable a successful Process Performance Qualification (PPQ).
Commercialization of ASDs requires statistical tools and methodologies to enable the continued process verification (CPV) application and ensure that the process remains under control. In this session, participants will gain insights into the importance of continuous improvement supported by continuous data analysis. The speakers will also outline the importance of commercial experience when using spray drying to produce ASDs. Case studies, namely regarding post approval changes, will be presented, and discussed.
Your Key Learning Objectives:
- Learn how to apply Quality Risk Management tools to get a successful Process Validation while ensuring a robust commercial stage.
- Learn how statistical tools support the commercial lifecycle enhancing process control and product quality.
- Discover how Continued Process Verification (CPV) and Product Quality Review (PQR) are key for a continuous improvement strategy.
Who Should Attend:
This webinar is suitable for anyone working in formulation and process development of amorphous solid dispersions, procurement, and outsourcing teams or project managers, who are interested in understanding the end-to-end process for validation and commercialization of an ASD by Spray Drying.
Watch On-demand.
Gated content. Registration is required.
Are you looking for a clear path from formulation screening to commercialization?
As an experienced manufacturer of ASDs by Spray Drying, Hovione will support your project by combining modeling capabilities, extensive process knowledge, and manufacturing capacity with an unmatched approval track record.