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Parenteral Drug Association Connecting People, Science and Regulation ®

Test Methods for Pre-filled Syringe Systems

Mar 21 - Mar 22, 2019 |
Mar 22, 2019 |
Hilton Molino Stucky Venice | Venice, Italy
  • Education
  • Europe
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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 both lecture leaders based on practical experience. The lecture includes the life cycle 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
  • Manufacturing Supervisors
  • Quality Personal / Regulatory Personal
  • Clinical and commercial Drug Product Manufacturing

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

Instructor

Horst Koller, CEO, HK Packaging Consulting
Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focusing 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 speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.

Thursday, 21 March 2019

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, 22 March 2019

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

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All fees given in Euro and excluding VAT (22%)

All Participants

1595 Euro

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Exterior

Hilton Molino Stucky Venice
Giudecca, 810
30133 Venice
Italy
Tel: +39 041 272 3311
Hotel Website

Once a flourishing flourmill, Hilton Molino Stucky Venice has been beautifully restored and offers a different view of the magical city of Venice. Just 30 minutes from the airport, we also offer a shuttle boat service to the city center. With 379 rooms and suites, the largest Congress Center and the second largest spa in Venice, a collection of bars and restaurants and a stunning rooftop pool, our hotel is the perfect location for your stay in Venice.

The comfort of their guests is a commitment reflected in the quality and finishes of their 379 rooms. Designed to be a place to unwind, all the rooms offer elegant amenities, spacious marble bathrooms and comfortable beds. Treat yourself with an upgrade and enjoy breathtaking views or access to the Executive Lounge.

Experience a real taste of the Mediterranean in the elegant Aromi restaurant or savor the authentic flavors of Venetian cuisine at Bacaromi. Spoil yourself with Nutella desserts or relax with a coffee at the lounge. Sip a cocktail Skyline Rooftop Bar enjoying outstanding views over Venice.

PDA Europe has reserved a limited number of rooms until the 19th December 2018.
Book Your Room for the PDA Group Rate

Single Room € 209 per night*
Double Room € 239 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • VAT, Taxes and Service Charge will apply

How to Get There

Venice Marco Polo Airport – VCE
Airport Phone: +39 041 260 9260

Hotel direction: 17 km
Airport shuttle service:

  • Public Boat: €15 per passenger (one way)
  • Public Bus: €8 per passenger (one way)
  • Public Taxi: €35 per passenger(one way)

Parking

  • On-site parking, fee: 4 EUR hourly, 12 EUR daily

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4751

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