Free to all IPEC members!
Featuring
Prof. Brian A Carlin, – Past IPEC-Americas QbD Committee Chair and President/Owner of Carlin Pharma Consulting LLC
R. Chris Moreton – IPEC-Americas Past Chair and Primary for FinnBritt Consulting
Mr. David Schoneker – IPEC-Americas QbD Committee Chair and President/Owner of Black Diamond Regulatory Consulting, LLC
Mr. Joseph Zeleznik – IPEC-Americas Chair and Director of Technical Services, IMCD US
Description
Revision of IPEC QbD guide review (what’s changed?)
Do excipient unknown unknowns derail your drug development project? What you don’t know about your excipients can impactyour product. The rational incorporation of excipients into quality-by-design (QbD) can inject robustness into your products and protect them against potential failures.
This webinar will review the impact of the IPEC QbD guide on product development and life-cycle management. Discussions will cover:
> The impact of excipient variability on product performance
> critical material attributes
> excipient criticality during development and life-cycle management
> product and process drift
> special cause variation
> user/maker expectations on samples and data
Learning/Awareness Objectives
Attendees will be able to demonstrate understanding of:
> QbD and pharmaceutical formulation development concepts for excipient manufacturers and suppliers
> Obtaining appropriate samples for QbD studies
> how changes to pharmaceutical formulation practices impact manufacturers and suppliers
> what excipient users may require when applying QbD principles during product development
> importance of feedback to stakeholders regarding what may or may not be possible when considering the impact of excipient variability in the application of QbD principles during product development.
Who should attend?
The revised guide is applicable to excipient use throughout the pharmaceutical product development process using a QbD approach, therefore, this webinar is applicable to personnel from regulatory, purchasing, quality, R&D, and manufacturing areas.