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Post-Conference Workshop: 2023 PDA Sponsored Workshop: Alternative Methods - Transforming Manufacturing Quality Control

The 2023 PDA Asia Pacific Regulatory Conference, will be held on 28-29 November 2023.

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

Speakers

Jenny Burnett

Head, Manufacturing Quality Branch at Therapeutic Goods Administration

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Matt Davis

Inspections Team Leader at Therapeutic Goods Administration - Australian Government

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Qing (Joanna) Zhou

Review Chief in the Office of Biotechnology Products, CDER at US Food and Drug Administration

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Peter Qiu

External Advocacy Lead China at Roche Genentech

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Ben Stevens

Director, CMC Policy and Advocacy of GSK

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Chris (Kwangyong) Nam

Director, Quality Assurance of Samsung Bioepis

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Marguerite Evans Galea

Director, Cell & Gene Catalyst of AusBiotech

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Lisa Bennett (Chair)

Senior GMP Consultant and Trainer at SeerPharma

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See all speakers

Agenda

Opening Plenary
Welcome Remarks
Keynote Speech: Update from PIC/S
Keynote Speech: National CGT Manufacturing Blueprint
Panel Discussion and Q&A
Opening Remarks
Updates from the PDA Advisory Boards
Session 4: Mature Pharmaceutical Quality Systems Enabling Ease of Post Approval Change Management
Quality Management Maturity (QMM)
Points to Consider for the Implementation of ICHQ12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
See full agenda

Location

Pullman on the Park
192 Wellington Parade
Melbourne, Victoria, Australia

See route

Contact us

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

Post-Conference Workshop: 2023 PDA Sponsored Workshop: Alternative Methods - Transforming Manufacturing Quality Control

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.


Sign Up For Workshop - Click Here!

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