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:
Head, Manufacturing Quality Branch at Therapeutic Goods Administration
Inspections Team Leader at Therapeutic Goods Administration - Australian Government
Review Chief in the Office of Biotechnology Products, CDER at US Food and Drug Administration
External Advocacy Lead China at Roche Genentech
Director, CMC Policy and Advocacy of GSK
Director, Quality Assurance of Samsung Bioepis
Director, Cell & Gene Catalyst of AusBiotech
Senior GMP Consultant and Trainer at SeerPharma
Pullman on the Park
192 Wellington Parade
Melbourne, Victoria, Australia
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.