Post-Conference Workshop: Patient Safety Evaluation for Single-Use Manufacturing - Click Here
Pre-Conference Site Visit: CelltrionPharm Pre-Filled Syringes Facility Site Visit - Click Here
The 2022 PDA Aseptic Processing of Biopharmaceuticals Conference will address topics related to the manufacturing of sterile drug products and patient-friendly applications. This year's conference will build up on last year's theme including topics involving challenges in isolators, glove leak testing, pre filled syringe installations, use of robotics in aseptic filling, and recent innovations in visual inspections. It will also introduce Industry 4.0 in Aseptic filling, advances in glass technologies and Quality in Biotherapy Production.
Our regulatory section will include the participation of MFDS, India and ex-US FDA inspectors providing Regulatory information about changes that will affect the pharmaceutical manufacturing environment and also how to manage regulatory inspections.
Presentation topics will be divided into three sections:
Simultaneous Interpretation/Translation (SI) English - Korean will be available
Auditors, Audit Specialists, Audit Managers, Area Managers, Biotech Managers, Head of Plant, Head of Quality Compliance, Engineering Managers, Managing Directors, Microbiologists, Product Managers, Production Managers, Packaging Specialists, Pharmacists, 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
Senior Director and Global Head of the Technical and Scientific Solutions at Merck
Product Manager at Stevanato Group
Area Manager Asia Pacific at Tema Sinergie S.p.A.
Technical Key Account Manager at Datwyler Pharma Packaging
Vice President - Head of the Global Drug Product Expansion Division at Celltrion, Inc.
Managing Director of One One Eleven GmbH
Vice President at Intellective Bio
Glass Converting Quality Manager, LST at Corning Pharmaceutical Technologies
Sheraton Grand Incheon Hotel
153 Convensia-Road, Yeonsu-gu
Incheon, Korea (South)
Rest well during your Incheon visit with the Sheraton Signature Sleep Experience in our Premium Hotel.
High ceilings and spacious bathrooms with soothing rainfall showers. Plan an unforgettable day in Incheon with high-speed Wi-Fi available in all accommodations.
You will find the information for your online reservation link below. If you have questions or need help with the link, please do not hesitate to ask. We appreciate your business and look forward to a successful event.
Start Date: Thursday, October 20, 2022
End Date: Monday, October 31, 2022
Last Day to Book: Thursday, September 22, 2022
We are offering your special group rate for 200,000 KRW - 250,000 KRW per night
Phone Number: +82 32 835 1145
COVID-19 protocols for international travelers
Extractables studies are performed to plan the risk mitigation and to identify potential leachables from the product contact parts for the pharmaceutical dosage forms. The approach to toxicological safety evaluation of extractables and leachables to address the safety concern will depend on the formulation of the drug product, route of administration and the duration of administration to the patient. The workshop will enable the attendees, through case studies, to understand the approaches to safety evaluations by applying the concepts stepwise in the toxicological evaluation of individual extractables or leachables.
At the end of the workshop the attendees will:
CelltrionPharm Bio Complex is a state-of-the-art facility designed and qualified to fill and package syringes and auto injectors at high speeds. Its CMO services convey the latest innovation in pharmaceutical technology. Implementing single use (SUS) technologies, filling under isolator with integrated EM, automated globe-leak-test using RFID, 100% automatic visual inspection, continuous syringe assembly and labeling, packaging syringes and auto injectors in various formats, and a robotic operated auto injector assembly machine (90upm), considered the fastest in the industry, CelltrionPharm Bio complex represents a globally recognized best-in-class, GMP compliant, Aseptic Filling and packaging of Biopharmaceuticals operations.
The site visit is exclusively free for all registered attendees of the 2022 PDA Aseptic Processing of Biopharmaceuticals Conference.
Please note that pre-registration is required as seats are limited to 40 pax on a first come first serve basis.