2023 PDA Asia Pacific Regulatory Conference

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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

Agenda

Tuesday, November 28, 2023 8:45^AM to 5:25^PM: 8:45^AM - 8:50^AM
Opening Plenary; 8:50^AM - 9:00^AM
Welcome Remarks; 9:00^AM - 9:30^AM
Keynote Speech: Update from PIC/S; 9:30^AM - 10:00^AM
Keynote Speech: National CGT Manufacturing Blueprint; 10:00^AM - 10:20^AM
Panel Discussion and Q&A

Wednesday, November 29, 2023 9:00^AM to 5:30^PM: 9:00^AM - 9:05^AM
Opening Remarks; 9:05^AM - 9:20^AM
Updates from the PDA Advisory Boards; 9:20^AM - 9:25^AM
Session 4: Mature Pharmaceutical Quality Systems Enabling Ease of Post Approval Change Management; 9:25^AM - 9:50^AM
Quality Management Maturity (QMM); 9:50^AM - 10:15^AM
Points to Consider for the Implementation of ICHQ12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

See full agenda

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!