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2022 PDA Annex 1 Workshops

One Agenda. Four Dates.

The highly anticipated revision of Annex 1 is expected to be published in early 2022.

To assist you in understanding the new requirements and preparing for anticipated challenges in implementation, PDA has 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.

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The 2022 PDA Annex 1 Workshop will be offered at the following times and locations:

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.

 

Watch the Workshop Previews!

For insights on some of the thought-provoking issues that will be addressed during the workshop, watch our series of short workshop previews:

Regulatory Insights

(18 mins.)

Watch Now
Environmental Monitoring

(24 mins.)

Watch Now
Cleanroom Design

(15 mins.)

Watch Now
 

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