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Parenteral Drug Association Connecting People, Science and Regulation ®

Test Methods for Pre-filled Syringe Systems

Jun 28 - Jun 29, 2018 |
Jun 29, 2018 |
Berlin Mariott Hotel | Berlin, Germany
  • 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

Instructors

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.


Roman Mathaes, PhD, Senior Group Leader, Lonza Drug Product Services
Roman is leading the Lonza particle lab and the container closure integrity testing. In this role, he is responsible for container closure integrity testing of vials and Pre-filled syringes and process development of capping / crimping. Prior to this assignment, Roman was working within Roche / Genentech network supporting process development of the commercial manufacturing vial capping process. Roman is a pharmacist by training and conducted his studies at the University of Marburg and King’s College London. He holds a PhD in Pharmaceutical Technology from the University of Munich for work on subvisible particle characterization.

Thursday, 28 June 2018

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, 29 June 2018

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 Participants

1495 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

Berlin Mariott Hotel
Inge-Beisheim-Platz 1
10785 Berlin
Germany
Tel: +49-30-220000
Hotel Website

Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

PDA Europe has reserved a limited number of rooms until the 12th May 2018.
Book your room for the PDA Group Rate.

Single Room € 195 per night*
Double Room € 215 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • VAT, Taxes and Service Charge will apply

How to Get There

Berlin-Tegel Airport – TXL
Airport Phone: +49 30 60911150
Hotel direction: 5.6 miles SE

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 60911150
Hotel direction: 12.3 miles NW

This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 3.5 EUR hourly, 30 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=4197

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