Main Conference: 2023 PDA Asia Pacific Regulatory Conference

The control of microorganisms in manufacturing processes and environments is crucial for enhancing the safety and efficacy of pharmaceutical products. In the past two decades, significant advancements have been made in modernizing the test for bacterial endotoxins (BET) and sterility test, due to the development of novel technologies such as recombinant Factor C (rFC) and rapid microbiological methods (RMM).

Recent progress is further evident by adoption of these technologies as compendial methods in Europe, and approval of parenteral medicines using these methods for release testing by multiple global regulatory authorities.


This workshop aims to provide insights into alternative methods, current compendial and regulatory trends worldwide, present case studies showcasing successful implementations of these methods and discuss their impact on advancing quality control processes.

Speakers

Agenda

Registration
Welcome and opening remarks by bioMerieux
Bacterial Endotoxin Testing – Progressive Science and Sustainability
Coffee Break
Transforming Sterility Testing in Australia: CBE Pure Solutions' Pioneering Journey
See full agenda

Location

Pullman on the Park
192 Wellington Parade
Melbourne, Australia

See route

Contact us

For additional event or venue information, please email asia-pacific@pda.orgYou can also reach us at +65 64965504

2023 PDA Asia Pacific Regulatory Conference

The 2023 PDA Asia Pacific Regulatory Conference is an in-person event that will be held on 28 - 29 November 2023 at Pullman on the Park in Melbourne, Australia.


Hear, experience, and learn from the regions' top global regulators and industry experts on topics such as:

  • ICHQ9 - QRM
  • ICHQ12 - Pharmaceutical Product Lifecycle Management
  • ICHQ1: Stability Testing Guidelines
  • ATMP
  • Annex 1 Implementation
  • Phase-appropriate GMP
  • AI/ ML and Emerging Technologies


Sign Up For Main Conference Here!

Related Events

  • 2023 PDA Pharmaceutical Microbiology Conference​
  • 2022 PDA Rapid Microbial Methods Workshop Oct 12 - Oct 13, Washington, DC
  • 2021 PDA Endotoxins Workshop 7 October
  • 2019 PDA Rapid Microbial Methods Workshop October 23-24 Rockville MD
  • 2019 2 day Training course: Classical or Rapid Microbiological Methods? The best approach for the modern pharmaceutical lab
  • 2018 PDA Endotoxins Workshop October Bethesda MD
  • 2018 2 day Training course: Rapid Microbiological Methods
  • Recurrent topic of podium presentations at PDA conferences such as Annual PDA Global Conference on Pharmaceutical Microbiology

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