PDA EU00195 Test Methods for Pre-Filled Syringe Systems

Piombino Dese, Italy
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Program Highlights

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

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 instructors. The lecture includes the lifecycle of a PFS, from the idea to the finished marketed product.

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
  • Quality Personal / Regulatory Personal
  • Clinical and commercial Drug Product Manufacturing
Learning Objectives
  • 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
Event Location
Stevanato Group Headquarter
Via Molinella 17, Piombino Dese, Italy 35017 Get Directions

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
training-europe@pda.org
Registration Customer Care

Standard Registration

Member Price

€ 2.090

Non-Member

€ 2.090

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Monday, 18 November 2024

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 Method 1 on Break Loose and Gliding Force on Empty Syringes
  • Test Method 2 on Closure Removal (POF of RNS and LLA Unscrewing)

17:45
Wrap-up of Training Course Day 1

  • Questionnaire

18:00
End of Day 1 and Transfer to Networking Dinner

Day 2

Tuesday, 19 November 2024

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 on Pre-Filled Syringes

15:30
Coffee Break

16:15
Wrap-up of Training Course Day 2

  • Questionnaire and Evaluation

16:45
End of Training Course

Agenda is subject to change.

Featured Trainers

  • Mattia Griso

    Stevanato Group

    Read Bio

  • Horst Koller

    HK Packaging Consulting GmbH

    Read Bio

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.

Stevanato Group Headquarter

Via Molinella 17
Piombino Dese, Italy 35017, Italy

Training Location

Stevanato Group Headquarter
Via Molinella 17
Piombino Dese
35017 Italy

Hotels Nearby

PDA Europe recommends the reservation at the following hotels.
The general terms of business are valid at the event hotels.

The following hotel is around 15 minutes walking distance away from the trainings venue.

Ca de Memi
Via Roma, 4,
35017 Piombino Dese, Italy
Hotel Website


All following hotels are around 20 minutes away by car from the trainings venue. PDA provides a shuttle bus from one fixed meeting point in Castelfranco to the training venue.

Albergo Moretto
Via S. Pio X, 10,
31033 Castelfranco Veneto TV, Italy
Hotel Website

Albergo Roma
Via Fabio Filzi, 39
31033 Castelfranco Veneto TV, Italy
Hotel Website

Hotel Alla Torre
Piazzetta Trento e Trieste,
31033 Castelfranco Veneto TV, Italy
Hotel Website

Hotel Fior
Via dei Carpani,18,
31033 Castelfranco Veneto TV , Italy
Hotel Website

How to Get Here
By Air Closest airport MARCO POLO Venecia.
By Car Around 40 minutes away from airport MARCO POLO Venecia.
By Other Options By Train: Around 60 minutes with public transportation from the airport MARCO POLO Venecia.