PDA Pacific Northwest Chapter: Use Computerized Tools to Support & Elevate Your Stability Program

Woodinville, WA
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This is an in-person and virtual event! Please see Agenda for details.

Gain a better understanding of supporting stability programs with computerized tools. This presentation will begin by mapping out the flow of data within the Stability process considering manual or digitized formats. Data Integrity (DI) requirements (FDA, MHRA, EMA, and PICS) will be reviewed and applied to the individual workflow steps. This includes defining metadata, au-dit trails, static vs dynamic forms, cGMP records, access rights, generation of data, retention of data, data use for decision-making, data archival, and electronic signatures. A risk assessment, including DI considerations, on the mapped stability process workflow will be shown using DI requirements and computerized tools to improve the Stability process workflow.

Student and Early Career Professional discounts available. Reach out to: [email protected]

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Day 1

  • 5:30pm | Doors open
  • 5:30 pm - 6:00 pm | Networking
  • 6:00 pm - 7:00 pm | Dinner
  • 6:15pm - 8:00 pm | Virtual meeting open
  • 6:30 pm - 8:00 pm | Presentation
  • 8:00 pm - 8:30 pm | Closing and final networking

Zoom meeting information coming soon.

Agenda is subject to change.

Featured Presenters

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