2023 PDA Aseptic Processing of Biopharmaceuticals Conference |Parenteral Drug Association EventBank

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Pre-Conference Site Visit: Hanmi Pyeongtaek Bioplant Site Visit - Click Here

UPDATE: Site Visit Registration Closed Due to Full Capacity. If you are still keen on attending the site visit, we encourage you to reach out to us at

asia-pacific@pda.org. We will gladly place your name on a waiting list, and in the event that additional spots become available, you will be given priority access.

The 2023 PDA Aseptic Processing of Biopharmaceuticals Conference is back and it will focus on the manufacture of sterile drug products and patient-friendly applications. An exhibition will be held alongside the conference to provide delegates and industry partners alike with the opportunity to network.

Date:31 October - 1November 2023 | Venue:Incheon, South Korea

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

CCS/ Annex 1 Implementation
Aseptic Processing: Techniques, Technologies & Updates
Cell & Gene Therapy
Human Error Reduction & Quality Improvements
Drug, Devices and Packaging

A site visit to the Hanmi Facility is scheduled the day before the two-day conference.

Site Visit Registration Closed Due to Full Capacity

Date: 30 October 2023

Time: 9:30 am - 5:00 pm

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

어젠다

2023년 10월 31일 화요일 08:30 부터 17:25: 08:30 - 08:35
Session I - Opening Session-Regulatory Agency Perspective; 08:35 - 08:55
Regulatory Trends in Aseptic Processing; 08:55 - 09:15
FDA Perspective on Pre-Approval Inspections, Common Findings and Factors Leading to Success; 09:15 - 09:30
Q&A Session; 09:30 - 10:00
Coffee Break at the Exhibition Hall

2023년 11월 1일 수요일 09:00 부터 17:40: 09:00 - 09:05
Session V - Human Error Reduction and Quality Improvement in Aseptic Environment, Part I; 09:05 - 09:25
MFDS inspection lessons learned or trend/example; 09:25 - 09:45
Quality Management Maturity Guidelines; 09:45 - 10:15
Panel Discussion and Q&A; 10:15 - 10:45
Coffee Break at the Exhibition Hall

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