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

    Revolutionizing Process Design with GenAI: The Kindeva Approach to Manufacturing Excellence

    This presentation introduces a groundbreaking GenAI-powered approach, as utilized at Kindeva's new Fill-Finish manufacturing facility. By adopting an integrative, end-to-end strategy, Kindeva leverages Generative AI to centralize and automate the design and control of manufacturing processes. A repository of hundreds of micro-process steps enables computer-generated and highly controlled outputs for process design, risk assessment, SOPs, MBRs, monitoring, and training.

    • 

      Sebastian Scheler, MSc
      Managing Director, Innerspace

    • 

      Jeffrey Gensler
      VP Quality, Kindeva Drug Delivery

  • 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

    In-process controls form a critical part of the contamination control strategy in pharmaceutical production.

    
    

    Recent regulatory updates will be discussed, how to apply the requirements whilst maximising the value of the data generated.

    
    

    The talk will also discuss some case studies relating to out of trend and out of specification results, how investigative testing and root cause analysis can remediate issues to reduce the likelihood of future failures.

    
    

    The talk will also cover manufacturing hold times and the information needed to support them, and how routine monitoring may support the holistic contamination control strategy. 

    • 

      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