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2022 PDA Annex 1 Workshops

One Agenda. Four Dates.

The highly anticipated revision of Annex 1 was just released and the deadline for coming into operation is 25 August 2023!

To assist you in understanding the new requirements and preparing for challenges in implementation, we developed the 2022 PDA Annex 1 Workshop!

This interactive workshop will be offered four times in 2022 to make it possible for you to participate in the option that best suits your schedule and your time zone. Only two workshops are left!

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Join us for one of the upcoming workshops:

What to Expect

The agenda will be the same for all four workshops! Explore the schedule and session topics:

  • Day 1
    • 8:00Welcome and Introduction

    • 8:15Session 1: Overview and Revision Process of Annex 1

    • 9:30Break

    • 10:00Session 2: Scope, Principles, and PQS

      Breakout Session 1
    • 12:00Lunch Break and Exhibition

    • 13:00Session 3: Premises and Barrier Systems

      Breakout Session 2
    • 14:55Break

    • 15:25Session 4: Equipment, Technology, and Utilities

      Breakout Session 3
    • 17:30Networking Reception

  • Day 2
    • 8:00Day 1 Highlights

    • 8:15Session 5: Personnel: Training, Qualification, Gowning, and Monitoring/Assessment

      Breakout Session 4
    • 9:45Break

    • 10:15Session 6: Production Technologies, Part 1

      Breakout Session 5
    • 12:00Lunch Break and Exhibition

    • 13:00Session 7: Production Technologies, Part 2

      Breakout Session 6
    • 14:30Break

    • 15:00Session 8: Aseptic Process Simulation/Environmental Monitoring

    • 16:00Q&A and Final Panel Discussion

    • 16:30Workshop Ends

*Times may vary by location.

 

Who Should Attend

Functional Areas
  • Quality Control (Analytical)
  • Quality Control (Microbiology)
  • Quality Systems
  • Quality Compliance
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Regulatory Affairs
  • Technical Operations
  • Training
  • Validation
  • Facilities
  • Packaging

Learning Objectives

At the completion of this workshop, participants will be able to:

  1. Gain awareness of the requirements and changes in Annex 1 and move towards compliance with the proposed changes in the revision
  2. Develop strategies for implementation and verification of the Annex 1 requirements, respectively, for their organizations
 

Exhibit and Sponsorship Opportunities