PDA Aseptic Processing of Biopharmaceuticals Conference 2024

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The PDA Aseptic Processing of Biopharmaceuticals Conference 2024 is back and it will be happening on 29 - 30 October 2024 in Incheon, Korea! More information on the theme and schedule coming soon.

Auditors, Biotech Managers, Head of Plant, Head of Quality Compliance, Engineering Managers, Microbiologists, Product Managers, Production Managers, Packaging Specialists, Quality Assurance Managers, Regional Sales Managers, Regulators, Regulatory Inspectors, Quality Control Managers, Quality Operations Managers, Regulatory Specialists, Scientists, Sterile Processing Specialists, Technical Account Specialists, Technical Directors, Unit Managers

Agenda

Tuesday, October 29, 2024 08:00 to 18:00: 08:00 - 08:45
Registration; 08:45 - 09:15
Sterilization Method Per FDA/EAM Perspective; 09:15 - 09:20
SESSION I: Particle Control; 09:20 - 09:50
Regulatory Updates and Compliance Challenges for Particulate Matter in Parenteral Preparations; 09:50 - 10:10
Q&A Session

Wednesday, October 30, 2024 08:30 to 17:10: 08:30 - 09:00
Registration; 09:00 - 09:05
Session V: Recent FDA Pre-approval/Pre-license Inspection Learnings; 09:05 - 09:35
Lessons Learned from Pre-approval/Pre-license Inspection: Explaining Observations for Better Understanding; 09:35 - 10:05
Microbial Control and Cleaning; 10:05 - 10:25
Panel Discussion and Q&A

See full agenda