PDA Pharmaceutical Manufacturing & Quality Conference 2025

SGT Standard Time (UTC +8:00)

• 08:00 – 09:00

  Registration

• 09:00 – 10:10

  Opening Session

  • 

    Samuel Tan
    Head of Operations & Strategy, Novartis Singapore Pharmaceutical Mfg Pte Ltd

  • 09:00 – 09:10

    Opening Remarks by the Committee Chairperson

    • 

      Samuel Tan
      Head of Operations & Strategy, Novartis Singapore Pharmaceutical Mfg Pte Ltd

  • 09:10 – 09:40

    Keynote Speech
  • 09:40 – 10:10

    New expectations from FDA
• 10:10 – 10:40

  Coffee Break at the Exhibition Hall

• 10:40 – 12:30

  Session 1: New Modality/Technologies

  • 10:40 – 10:45

    Welcome Remarks by the Moderator
  • 10:45 – 11:15

    Factory of the Future - Autonomous Vaccines Manufacturing
  • 11:15 – 11:45

    Antibody-Drug Conjugate (ADC)
  • 11:45 – 12:30

    Panel Discussion and Q&A
• 12:30 – 14:00

  Lunch Break

• 14:00 – 15:35

  Session 2: Quality and Regulatory Compliance

  • 14:00 – 14:05

    Welcome Remarks by the Moderator
  • 14:05 – 14:35

    Bioburden Challenges & Control
  • 14:35 – 15:05

    TBC
  • 15:05 – 15:35

    Panel Discussion and Q&A
• 15:35 – 16:05

  Coffee Break at the Exhibition Hall

• 16:05 – 17:35

  Session 3: Operational Excellence in Manufacturing

  • 16:05 – 16:10

    Welcome Remarks by the Moderator

    • 

      Samuel Tan
      Head of Operations & Strategy, Novartis Singapore Pharmaceutical Mfg Pte Ltd

  • 16:10 – 16:40

    Continuous Improvement Culture
  • 16:40 – 17:10

    Application of GenAI
  • 17:10 – 17:40

    Panel Discussion and Q&A

SGT Standard Time (UTC +8:00)

• 08:00 – 09:00

  Registration

• 09:00 – 10:35

  Session 4: Microbiology Part 1

  • 09:00 – 09:05

    Welcome Remarks by the Moderator
  • 09:05 – 09:35

    CCS From The Perspective of An Ex-Regulator: 2 Years Post Annex 1 Where and Why Are We Still Struggling On Implementing

    • 

      Andy Hopkins
      Senior Director, Lachman Consultants

  • 09:35 – 10:05

    Sterility Assurance – Meeting an Unmet Industry Technical Need on Design and Operation of RABS Systems

    • 

      Bruce A. Loxley
      Regulatory Inspection Compliance Director, GSK

  • 10:05 – 10:35

    In-Process Controls in Pharmaceutical Production: What to Test and How to Use the Results

    • 

      Miriam Guest
      Senior Principal Scientific Advisor, Charles River Labs, Microbial Solutions

• 10:35 – 11:05

  Coffee Break at the Exhibition Hall

• 11:05 – 12:35

  Session 5: Microbiology Part 2

  • 11:05 – 11:35

    Disinfectant Field Study
  • 11:35 – 12:05

    Environmental Monitoring Performance Qualification of New Facilities (EMPQ) in New Facilities: Application of Industry Harmonized Approach

    • 

      Hillary Chan
      Global Sterility Assurance and Microbiology Lead, Takeda

  • 12:05 – 12:35

    Panel Discussion and Q&A
• 12:35 – 14:05

  Lunch Break

• 14:05 – 15:05

  Session 6: Microbiology Part 3

  • 14:05 – 14:35

    Frailty of H2O2 As A Sterilization Method
  • 14:35 – 15:05

    TBC
• 15:05 – 15:35

  Coffee Break at the Exhibition Hall

• 15:35 – 17:05

  Session 7: Microbiology Part 4

  • 15:35 – 16:05

    Low Endotoxin Recovery Challenge and QC Case Study

    • 

      Jennifer Cheung
      VP of Global Quality Assurance Operations, Gilead Sciences

  • 16:05 – 16:35

    Sustainability Topics in Microbiology
  • 16:35 – 17:05

    Panel Discussion and Q&A
• 17:05 – 17:15

  Closing Remarks