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일정
등록
오프닝 세션
Annex 1: Key Regulatory Shifts and Their Impact on Facilities
Implementation Challenges and Solutions in Aseptic Fill-Finish Facilities
휴식 시간
Environmental Monitoring (Performance Qualification) Approaches vs. Real World Cases: Insights Uncover Myths
Strengthening Smoke Study Practices: A Case Study in Aseptic Manufacturing
Integrating Risk-Based Approaches in Contamination Control Strategy: An Inspector’s View
Q&A and Panel Discussion
점심 시간
Closed Systems, Robotics, and Isolator Technologies
Aseptic Manufacturing for mRNA, ADCs, and Novel Biologics
휴식 시간
Adopting USP Chapter <86>: Efficiently Transitioning to Recombinant Endotoxin Testing and Case Study
Building a Culture of Compliance and Continuous Improvement
Q&A and Panel Discussion
Common Data Integrity Pitfalls Observed During Inspections: Intentional, Unintentional and Systemic Vulnerabilities
Audit Findings: Common Data Integrity Gaps
휴식 시간
Geopolitical impact on supply chain of medicines for Aseptic Manufacturers
Cold Chain Management for Biologics and Cell Therapies
Q&A and Panel Discussion
점심 시간
Primary Packaging Compatibility, Sterility and The Use For High Potent Products
CCS in Sterile Packaging & Compliance Update
RTU Primary Packaging and Aseptic Transfer: An Integrated Perspective
휴식 시간
Aseptic Processing for ATMPs: Facility and Process Design
Regulatory & Ecosystem Framework Updates on Regenerative Medicine: A RMAF Korea Perspective
Regulatory and Quality Considerations for CGT Manufacturing: A Japan Perspective
Q&A and Panel Discussion
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