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PDA EU00152 Test Methods for Pre-Filled Syringe Systems

Apr 20 - Apr 21, 2023
TBA,

  • Education
  • Europe
Program Highlights

The participants of this course will benefit from first hand information of the instructor based on practical experience.

Overview

The course will be an interactive lecture around Pre-Filled Syringe Systems including ISO compliance testing. The participants will benefit from first hand, based on experience, information from the instructor. The lecture includes the lifecycle of a PFS, from the idea to the finished marketed product.

Agenda

  • Day 1
  • Day 2
  • Thursday, 20 April 2023


    09:00
    Welcome


    09:00
    Introduction to Syringe Systems and Components


    10:30
    Coffee Break


    11:00
    Luer Cone and Luer Lock Compliance Testing for Glass and Polymer Syringes

    • Compliance and Connectivity

    12:30
    Lunch Break

    13:30
    Requirements for the Empty Sterile Sub-Assembled Syringes Ready for Filling- Part 1

    • Cone Breakage / Flange Breakage / Leakage Testing

    15:15
    Coffee Break


    15:45
    Requirements for the Empty Sterile Sub-Assembled Syringes Ready for Filling- Part 2

    • Break Loose and Gliding Force / Needle Testing

    16:45
    Hands-on Training

    • Test methods described in part 1 & part 2

    17:30
    Wrap-up of Day 1


    15:45
    End of Day 1

  • Friday, 21 April 2023


    09:00
    Regulatory Requirements of Finished Pre-Filled Syringes – Part 1

    • Pharmaceutical Characterization / System Characterization / Physical Characterization

    10:30
    Coffee Break


    11:00
    Regulatory Requirements of Finished Pre-Filled Syringes – Part 2

    • Pharmaceutical Characterization / System Characterization / Physical Characterization

    12:30
    Lunch Break

    13:30
    Upcoming Changes of ISO Standards on Pre-Filled Syringes

    • Empty Sterile Sub-assembled Syringes Ready for Filling
    • Finished Pre-Filled Syringes

    14:15
    Testing of Syringes for Use in Delivery Devices


    15:15
    Hands-on Training

    • Test methods described in Part 1 and Part 2

    15:30
    Coffee Break


    16:15
    Wrap-up of Day 2


    15:45
    End of Training Course

Trainers

Horst Koller
Horst Koller
HK Packaging Consulting GmbH

Additional Information

  • Learning Objectives

    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

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  • Amenities
     

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Registration Fees

Regular Price
Registration Type Price
All Participants €1.895

All fees given in Euro and excluding VAT


* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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