In association with
Why should you attend this event?
This half day masterclass will provide an overview of the relevant practical aspects of developing and designing pre-filled syringe systems focusing on functionality testing and regulatory issues. Within the course ready-to-fill syringe system concepts will be presented and discussed.
Where does the event take place?
This Master Class will take place in central London, UK
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What is this event about?
Recent years have seen a rise for pre-filled syringes from a niche product to the primary container of choice for most parenteral drug delivery systems. This is the result of a number of factors, although the improved safety and increased convenience of a pre-fillable device is the leading reason. The global market for pre-fillable syringes today comprises of more than 2.2 billion syringes, with over half of these supplied sterile. This Master Class aims to address the development of pre-fillable syringe systems as well as examine the documentation and regulatory issues faced by these systems.
Participants will learn the design approach for a pre-fillable syringe system in regards to functionality, container closure integrity, extractables and leachables, both from a vendor's and customer's perspective.
Who is leading this event?
The Master Class is being led by Horst Koller, Head of Regulatory Affairs, SCHOTT forma vitrum.
Masterclass agenda
Horst Koller's experience and qualifications
Purpose and scope of the workshop
Development of Pre-Fillable Syringe Systems
From vial to a pre-filled syringe
Guidelines for Design
Functionality testing of syringe systems
Documentation and Regulatory Issues of Pre-Fillable Syringe Systems
Compendial Testing
Stability Testing
Container Closure Integrity
Compatibility Testing
VENUE
Crowne Plaza Hotel - St James
Buckingham Gate 45/51, London, United Kingdom
A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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