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).

UPDATE: Site Visit Registration Now Closed Due to Full Capacity

We are pleased to announce that registration for the site visit has reached full capacity and is now officially closed. Due to the overwhelming interest, we are unable to accept any additional registrations at this time.

For those who have successfully registered, you should have received a confirmation email. We look forward to welcoming you to the site visit.

If you have any further questions or need assistance, please feel free to reach out to us at asia-pacific@pda.org.

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 18:00: 08:00 - 08:35
Registration; 08:35 - 08:50
SESSION I: Particle Control; 08:50 - 09:20
Sterilization Processes – 2024 What Do We Do Now?; 09:20 - 09:50
Using Quality Risk Management to De-Risk Aseptic Processing Operations; 09:50 - 10:10
Q&A Session

Wednesday, October 30, 2024 08:15 to 17:20: 08:15 - 08:50
Registration; 08:50 - 08:55
Session V: Recent FDA Pre-approval/Pre-license Inspection Learnings; 08:55 - 09:35
Environmental Monitoring Performance Qualification of New Facilities (EMPQ) in New Facilities: Application of Industry Harmonized Approach; 09:35 - 10:05
A Former U.S. F.D.A. Inspector’s Perspective on Annex 1 and Biologics’ Pre-approval/Pre-license Findings; 10:05 - 10:35
Microbial Control During Drug Substance Manufacturing

See full agenda

Secure a hotel room at the conference venue

PDA secured preferential rates for our delegates at Sheraton Grand Incheon during the conference. To book a room at the hotel, please use the link below.

Room Rate for Deluxe Rooms

Single Room Only at KRW 250,000