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2023 PDA Annex 1 Workshops

New Dates Added!

The new Annex 1 revision requirements went into effect on 25 August!

To assist you in understanding these new requirements and overcome challenges related to implementation, we have added more offerings of this successful workshop.

This interactive workshop will be offered two more times in 2023 to make it possible for you to participate in the option that best suits your schedule and your time zone.

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Join us for one of the upcoming workshops:

Antwerp
ANTWERP
09-10 November
Antwerp, Belgium
REGISTER
Charlotte
CHARLOTTE
04-05 December
Charlotte, NC
REGISTER

What to Expect

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

  • Day 1

    • 8:00Session 1: Overview and Revision Process for Annex 1

    • 9:30Break

    • 10:00Session 2: Scope, Principles, and Pharmaceutical Quality Systems

      Breakout Session 1

    • 11:45Lunch

    • 13:00Session 3: Premises and Barrier Systems

      Breakout Session 2

    • 14:45Break

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

      Breakout Session 3

    • 17:00Day 1 Q&A and Panel Discussion

    • 17:30Networking Reception

  • Day 2

    • 8:00Session 5: Personnel: Training, Qualification, Gowning, and Monitoring/Assessment

      Breakout Session 4

    • 9:45Break

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

      Breakout Session 5

    • 11:45Lunch

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

      Breakout Session 6

    • 14:30Break

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

    • 15:40Q&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 new changes in the revision
  2. Develop strategies for implementation and verification of the Annex 1 requirements, respectively, for their organizations
 

Exhibit and Sponsorship Opportunities