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2021 UPS_1988x680

PDA EU00152 Test Methods for Pre-filled Syringe Systems

Oct 07 - Oct 08, 2021
Gothenburg, Sweden

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

  • Education
  • Europe

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Program Highlights

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 the instructor 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, 07 October 2021

    9:00
    Welcome


    09:15
    Introduction to Syringe Systems and Components


    10:30
    Coffee Break

    11:00
    Regulatory Requirements of Finished Pre-filled Syringes – Part 1

    • System Characterization / Physical Characterization

    12:30
    Lunch Break

    13:30
    Regulatory Requirements of Finished Pre-filled Syringes – Part 2

    • Pharmaceutical Characterization

    15:30
    Coffee Break

    16:00
    Luer cone and Luer lock Compliance Testing for Glass and Polymer Syringes


    17:30
    Wrap-up of Day 1


    17:45
    End of Day 1
  • Friday, 08 October 2021

    9:00
    Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 1

    • Cone Breakage / Flange Breakage / Leakage

    10:15
    Coffee Break

    10:45
    Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 1 (cont.)

    • Cone Breakage / Flange Breakage / Closure Testing

    11:45
    Requirements for the Empty Sterile Sub-assembled Syringes Ready for Filling- Part 2

    • Break Loose and Gliding Force / Needle Testing / Particulate Matter

    13:15
    Lunch Break

    14:15
    Additional Testing for Use in Delivery Devices


    15:15
    Wrap-up of Day 2


    15:30
    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

    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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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

How to Get Here

By Air

Nearest Airport: Gothenburg-Landvetter Airport – GOT
Airport Phone:
+46 10 109 31 00

By Car

22.9 km, 20 min by car. Gothia Towers is located at Mässans gata 24, Göteborg.

E6/E20 (from the north) and road 45 (from Karlstad): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the first exit on the left, then turn right on to Örgrytevägen and then take the next right exit for the hotel.

E6/E20 (from the south) and road 40 (from Borås): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the second exit on the right for the hotel.

Other Options

Flygbussarna airport coach: to Korsvägen/the Swedish Exhibition & Congress Centre, opposite the hotel.

Public transportation: Korsvägen stop, 100 meters from hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT (25%)

* 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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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