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

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. [email protected]

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 [email protected] 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

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.

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.

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.