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2023 PDA_Training-1988x680

PDA EU00152 Test Methods for Pre-Filled Syringe Systems

Oct 19 - Oct 20, 2023
Gothenburg, Sweden

  • Education
  • Europe
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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.

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Agenda

  • Day 1
  • Day 2

  • Thursday, 19 October 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 Training Course Day 1

    15:45
    End of Training Course Day 1

  • Friday, 20 October 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 Training Course Day 2

    15:45
    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 28 years’ industry experience. His consulting company focuses 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 member of the WG16 for the EDQM. He is a speaker on international conferences and holds customized trainings. He has an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim, Germany.

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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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

  • Accommodations

    PDA recommends the reservation at the following hotel

    Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg,
    Sweden

    PDA Europe has reserved a limited number of rooms until the 15th August 2023.

    Book your room at the PDA Group Rate via the above-mentioned reservation button.

  • Amenities

    Just a 20-minute walk from the hotel you will find The Garden Society of Gothenburg - one of Europe's best-preserved 19th-century parks. At the other end of town you will find the Botanical Garden, a world-class botanical garden with over 16,000 species to admire.

How to Get Here

By Air

Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Korsvägen/Svenska Mässan. They run directly between these stops.

By Car

E6 / E20 (from north) and road 45 (from Karlstad): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Take the first exit on the left, turn right onto Örgrytevägen and then take the next exit right towards Svenska Mässan. E6 / E20 (from south) and road 40 (from Borås): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Then take the second exit right towards the hotel.

Other Options

From the main railway station take the number 2 tram (towards Krokslätt) or the 4 (towards Mölndal). From Brunnsparken Square you can also take the number 5 tram (towards Torp). The trams stop at Korsvägen / Svenska Mässan. Tram timetables can be found on the Västtrafik website.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.895

* 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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