Education Session

206 - Process Analytical Technology (PAT) Used for PQLI® and QbD: Implementation Update, Examples, and Discussion

9 November 13.30-17.00
ISPE CEUs: 0.25

Get Agenda Tracks: ProductRegulatoryQuality

There is a stated need by industry for concrete PAT/ QbD examples. PQLI and PAT concepts are well defined; however, there are still more questions than answers on how to successfully implement and why the industry would want to devote resources to these concepts. The groundwork has been laid, and now the time has come to determine how to successfully use the experience of others. The intent is not to stand up and teach the right answer, but to lead a discussion for discovery. This session will address the following topics:

  • Description and discussion of the four PAT tools
  • Benefits and value of PAT
  • Examples showing the combination of the PAT tools in one system, with a description of realized benefits
  • Question and answer session

This session content is rated advanced as attendees should understand the definitions, current guidance, and theory behind PAT, QbD, and PQLI.

How you will Benefit

At the end of this session, participants will be able to:

  • Understand how to communicate the concepts to stakeholders
  • Research and develop process data gathering projects using PAT/PQLI
  • Determine a path forward for utilization of process data for process improvement
  • Understand and determine the application of process improvement tools and methods in a validated environment

Who Should Attend

Professionals from process development, validation, quality, manufacturing, automation, and engineering

ISPE Communities of Practice (COPs)

Biotech, C®Q, GAMP, OSD, PAT, PPD, and PM

View the ISPE Community of Practice (COP) Guide

Session Leader

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