Incorporation of Pharmaceutical Excipients into a Quality-by-Design (QbD) Development Project

Category: IPEC Federation
  • IPEC-Americas - 3138 10th Street N. Suite 500 - Arlington, VA 22201 - United States
  • 13 Jan 2021

DESCRIPTION

Do excipient unknowns derail your drug development project?  What you don’t know about your excipients might surprise you, and could impact your 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 new IPEC QbD guide on product development and life-cycle management.  

Discussion will cover: 

  • 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
  • bridging the gap between user and maker expectations

LEARNING OBJECTIVES

Attendees will be able to:

  • describe QbD and pharmaceutical formulation development concepts to excipient manufacturers and suppliers,
  • understand how changes in pharmaceutical formulation practices, due to the introduction of QbD, impact excipient manufacturers and suppliers,
  • recognize what excipient users will likely require when applying QbD principles during product development,
  • provide feedback to excipient users and regulatory agencies regarding what may or may not be possible when considering the impact of excipient variability in the application of QbD principles during product development.

DATE AND TIME

Wednesday 13 January 2021 - 10:00 EST / 15:00 GMT / 16:00 CET


REGISTRATION FEES

IPEC Federation Member companies: FREE (applicable to IPEC Europe Members)
IPEC Federation Non Member companies: $ 59


PRESENTERS

Dave R. Schoneker, Consultant

Chris Moreton, Ph.D., Consultant, FinnBrit Consulting

Brian AC Carlin, Ph.D., Director QbD/Regulatory, DFE Pharma