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2020 Medical Device

Test Methods for Pre-filled Syringe Systems

Sep 10 - Sep 11, 2020
Madrid, Spain

The participants of this course will benefit from first hand information of both lecture leaders based on practical experience.

  • Education
  • Europe

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Program Highlights

Overview

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.

Agenda

  • Day 1
  • Day 2
  • Thursday, 10 September 2020

    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, 11 September 2020

    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

Trainers

Horst Koller
Horst Koller
HK Packaging Consulting GmbH

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

    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.

Novotel Madrid City Las Ventas

Albacete, 1
Madrid, Spain
Phone: +34 91 7247600

Novotel Madrid City Las Ventas
  • Accommodations

    Novotel Madrid City Las Ventas
    Albacete, 1
    Esquina avenida de badajoz
    28027 Madrid - Spain
    Tel: +34 91 7247600
    Fax: (+34)91/7247610
    E-Mail

    This modern hotel is conveniently located for both Madrids Barajas Airport and the city centre. After a day of work or travel you can unwind with a swim in the outdoor pool.Both metro and bus lines run directly to the city centre at Puerta del Sol. The trade fair site of Juan Carlos I is 4 km away, and can be easily accessed via the nearby M30 motorway.

    Enjoy a meal on site at the Insólito Restaurant, which serves Spanish cuisine made with fresh products. You can then relax in the Insólito cocktail bar with a drink. The hotel also has a chill out bar at the pool.

    PDA Europe has reserved a limited number of rooms until the 27th July 2020
    Single Room € 137 per night* 
    Double Room upon request
    *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 will apply
  • Amenities

How to Get Here

By Air

Nearest Airport:

Adolfo Suárez Madrid-Barajas Airport - MAD
Airport Phone: +34 913 211 000
At 5km / 3 miles

By Car

More information coming soon.

Other Options

Train Station: ATOCHA At 9km / 5.63 miles


Train Station: CHAMARTIN At 4km / 2.49 miles

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT (21%)

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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Tel: +1 (301) 656-5900 ext. 115
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