Skip To The Main Content
2019 UPS

Test Methods for Pre-filled Syringe Systems - Fall Edition

Oct 24 - Oct 25, 2019
Gothenburg, Sweden

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

  • Education
  • Europe

left to register

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, 24 October 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, 25 October 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

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
  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

Got a Question? We have answers

Contact Us

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.

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden

The Swedish Exhibition & Congress Centre Gothia Towers Hotel
  • Accommodations

    The Swedish Exhibition & Congress Centre Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg, Sweden


    Hotel Accommodation

    optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.

    You can book your Hotel Accomodation here!

  • Amenities

How to Get Here

By Air

Nearest Airport: Gothenburg-Landvetter Airport - GOT
Airport Phone: +46 10 109 31 00

By Car

22.9 km, 20 min by car. Gothia Towers is located at Mässans gata 24, Göteborg.

E6/E20 (from the north) and road 45 (from Karlstad): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the first exit on the left, then turn right on to Örgrytevägen and then take the next right exit for the hotel.

E6/E20 (from the south) and road 40 (from Borås): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the second exit on the right for the hotel.

Other Options

Flygbussarna airport coach: to Korsvägen/the Swedish Exhibition & Congress Centre, opposite the hotel.

Public transportation: Korsvägen stop, 100 meters from hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT (25%)

* 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).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

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 registration@pda.org. Phone messages are not accepted.

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

PDA Members Save Substantially