PDA Aseptic Processing of Biopharmaceuticals Conference 2024

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PDA Aseptic Processing of Biopharmaceuticals Conference 2024 is taking place on 29 - 30 October 2024 in Sheraton Grand Incheon, South Korea.

Over the two days, the conference will cover the following topics:

Particle Control
Points to Consider in Facilities Design
Annex I Implementation
Rapid Micro Methods (RMM)
CCS Implementation
Quality Management Maturity (QMM)
Digital Transformation
Combination Products
PDA Technical Reports and PTC Updates

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

Make it into a learning week with our site visit and workshop!

GC Biopharma Facility Site Visit

Admission to join the pre-conference site visit is free and exclusively available to all registered attendees on a first come first serve basis (Limited to 50pax).

PDA CDMO Partnership Workshop 2024

In this workshop you will learn

How to submit a winning RFP and a quality agreement
Go behind the scenes on how big Pharma evaluate CDMOs
Key considerations eg. capacity issues, capabilities, specific skill sets of CDMOs
Small CDMO vs Big CDMO, when and how to position yourself
How to manage tech transfer and quality management systems
How to be inspection ready, learn the regulatory complexities
A comprehensive template of a Master Transfer Plan including a RACI, roles and responsibilities, and timelines

Agenda

Tuesday, October 29, 2024 08:00 to 18:20: 08:00 - 08:45
Registration; 08:45 - 08:50
SESSION I: Particle Control; 08:50 - 09:20
Sterilization Method Per FDA/EAM Perspective; 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 17:15: 08:30 - 09:00
Registration; 09:00 - 09:05
Session V: Recent FDA Pre-approval/Pre-license Inspection Learnings; 09:05 - 09:35
Environmental Monitoring Performance Qualification of New Facilities Case Study: Application of Industry Harmonized Approach; 09:35 - 10:05
Lessons Learned from Pre-approval/Pre-license Inspection: Explaining Observations for Better Understanding; 10:05 - 10:35
Microbial Control and Cleaning

See full agenda