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2020 Medical Device

PDA Europe Virtual Training Course - Test Methods for Pre-filled Syringe Systems

Sep 10 - Sep 11, 2020
9:00 AM
-
6:00 PM
| W. Europe Standard Time
Online
  • Virtual
  • Education
  • Online
  • Europe
Register Now

Overview

The course will be an interactive lecture around Pre-filled Syringe Systems including ISO compliance testing. The participants will benefit from first hand information of both lecture leaders based on practical experience. The lecture includes the life cycle of a PFS from the idea to the finished marketed product.

Agenda

  • Day 1
  • Day 2

  • Thursday, 10 September 2020

    14:00
    Welcome

    Introduction to Syringe Systems and Components

    Regulatory Requirements of Finished Pre-filled Syringes – Part 1

    • System Characterization / Physical Characterization

    Regulatory Requirements of Finished Pre-filled Syringes – Part 2

    • Pharmaceutical Characterization

    Luer cone and Luer lock Compliance Testing for Glass and Polymer Syringes

    Wrap-up of Day 1

    15:30
    End of Day 1

  • Friday, 11 September 2020

    14:00
    Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 1

    • Cone Breakage / Flange Breakage / Leakage

    Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 2

    • Break Loose and Gliding Force / Needle Testing / Particulate Matter
    Additional Testing for Use in Delivery Devices

     

    Wrap-up of Day 2

    15:30
    End of Training Course

Trainers

Horst Koller
Horst Koller
HK Packaging Consulting GmbH
Bio
Horst Koller
HK Packaging Consulting GmbH

Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience.

His consulting company is focussing on Technical, Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices.

He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences.

He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.

Learning Objectives

Upon completion of the course the participants will have solid knowledge of

  • Materials used for PFS Systems
  • Luer Cone and Luer Lock Compliance Testing
  • Requirements for the empty sterile sub-assembled syringe ready for filling
  • Test Methods for Drug Product Filled Syringes
  • PFS used in Delivery Systems

Who Should Attend

The course is designed specifically for those who are involved or interested in the development, manufacturing and QC-testing of a Pre-filled Syringe System:

  • Engineers and Managers in Device Development and all other technical functions surrounding syringe systems
  • Manufacturing Supervisors
  • Quality Personal / Regulatory Personal
  • Clinical and commercial Drug Product Manufacturing

Registration Fees

Register Now
Registration Type Price
All Participants €400

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