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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:
Manufacturing:
- Aseptic Manufacturing using Isolators, design, new technologies
- Use of Robotics in Aseptic filling
- Glove leak rate detection
- RABS case study
- Developing a Pass through Decon best practice
- Primary packaging sourcing, advancement in Glass technology
- Regulatory expectations for Extractables & Leachables on packaging systems
- Important considerations for Aseptic techniques
Regulatory Updates
- MFDS perspective in vaccines (topic in progress)
- Best practices in Regulatory Inspections
Quality Assurance
- Aseptic operations, managing risks, quality monitoring
- Implementation of Novel systems
Simultaneous Interpretation/Translation (SI) English - Korean will be available
Who Should Attend
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
Accommodation: Sheraton Grand Incheon Hotel
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.
Bookings
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
BOOK YOUR GROUP RATE NOW - CLICK HERE
Contact Us
Email: June.kim@sheraton.com
Phone Number: +82 32 835 1145
FOR THE LATEST DETAILS ON COVID-19 ENTRY TO SOUTH KOREA - CLICK HERE
COVID-19 protocols for international travelers
- Since June 8th 2022, all travelers, regardless of their vaccination status and nationality, are exempt from quarantine.
- Starting from March 21st, 2022, all inbound passengers to Korea are required to enter their sanitary information on the Q-Code System, in order to receive a QR-Code to present to the Korean authorities upon arrival.
- Showing a negative PCR result issued within 48 hours before boarding, or a rapid antigenic test issued within 24 hours before boarding remains compulsory to enter the territory.
- Since July 25, all travelers must do a PCR test before midnight on the day after arrival (not within 3 days anymore) and input the result in the Q-Code System or inform its local Public Health Center (in case of foreign residents).
- These rules apply to all travelers: residents in Korea, long and short sojourn visa holders, tourists who have received their K-ETA (Korea Electronic Travel Authorization).
Patient Safety Evaluation for Single-Use Manufacturing
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.
Key Takeaways:
At the end of the workshop the attendees will:
- be able to understand the extractable reports
- understand the risk assessment process flow including USP <1665> and BioPhorum guidance
- be able to make a toxicological safety evaluation for a formulation by a case study.
CelltrionPharm Pre-Filled Syringes Facility Site Visit
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.
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