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Name: Process Analytical Technology (PAT) Used for PQLI® and QbD: Implementation Update, Examples, and Discussion ( WEBPATPQLI )
Description: 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 content is rated advanced as attendees should understand the definitions, current guidance, and theory behind PAT, QbD, and PQLI.
Objectives: At the conclusion 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
  • URL:
    CEUs: .25
    Member Price: US Dollar        EURO
    Non Member Price: US Dollar        EURO
    Instructors:
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