PDA Annex1 Implementation: Inspection Ready Workshop 2025

ICT Standard Time (UTC +7:00)

• 08:00 – 09:00

  Registration

• 09:00 – 10:15

  Opening Session

  • 09:00 – 09:15

    Introduction by Program Chair

    • 

      Richard Denk
      Senior Consulting Aseptic Processing & Containment, SKAN AG

  • 09:15 – 09:45

    Keynote: How Are The Current Trade Policies Affecting The Industry Regionally
  • 09:45 – 10:15

    Regulatory Roundtable: Adoption and Implementation of PIC/S Annex 1, Successes and Challenges Two Years On
• 10:15 – 10:45

  Coffee Break

• 10:45 – 12:15

  Session 1

  • 10:45 – 11:15

    Understanding Annex 1: Key RequirC15:C22ements and Regulatory Updates
  • 11:15 – 11:45

    Developing a Robust Contamination Control Strategy (CCS) for Compliance
  • 11:45 – 12:15

    Cleanroom Design and Environmental Monitoring: Meeting Annex 1 Standards
• 12:15 – 13:15

  Lunch Break

• 13:15 – 14:15

  Session 2

  • 13:15 – 13:45

    Personnel Training and Competency: Building a Culture of Compliance
  • 13:45 – 14:15

    Panel Discussion
• 14:15 – 15:00

  PIC/s Annex 1 Workshop/Training Part 1

  • 

    Richard Denk
    Senior Consulting Aseptic Processing & Containment, SKAN AG

• 15:00 – 15:30

  Coffee Break

• 15:30 – 17:00

  PIC/s Annex 1 Workshop/Training Part 2

  • 

    Somasundaram G.
    Associate Director, Merck Life Science Private Limited

ICT Standard Time (UTC +7:00)

• 08:30 – 09:00

  Registration

• 09:00 – 10:20

  Session 3

  • 09:00 – 09:40

    Equipment Qualification and Validation for Sterile Manufacturing
  • 09:40 – 10:20

    Sterility Assurance and Process Validation: Ensuring Consistency
• 10:20 – 10:50

  Coffee Break

• 10:50 – 12:40

  Session 4

  • 10:50 – 11:30

    Documentation, Batch Records, and Change Control for Inspection Readiness
  • 11:30 – 12:10

    GMP Inspections: Preparing for Success and Effective Response Strategies
  • 12:10 – 12:40

    Panel Discussion
• 12:40 – 13:40

  Lunch Break

• 13:40 – 15:00

  Mastering Contamination Control Strategy (CCS) for Annex 1 Compliance Part 1

• 15:00 – 15:30

  Coffee Break

• 15:30 – 17:00

  Mastering Contamination Control Strategy (CCS) for Annex 1 Compliance Part 2