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2019 UPS

All about Pre-filled Syringe Systems - From Initial Development to Final Fill Finish

Oct 24 - Oct 25, 2019
Gothenburg, Sweden

  • Education
  • Europe

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Overview

Join us on our journey from the components of a syringe to a customer needs oriented pre-filled syringe system. This two-day interactive course will provide an overview of relevant practical aspects and trends of developing and processing of pre-filled syringes. It will also address relevant regulatory requirements related to materials, components and processes of pre-filled syringes. Special focus is given to the perspectives of health care practitioners and patients covering the relationships of syringe properties with aspects of drug administration. In hands-on sessions participants will have the opportunity to study pieces of equipment such as syringes, stoppers, needle shields and tip caps in more detail. Processing steps, inspection and quality aspects will be demonstrated using state-of-the-art technology. Discussions of real case examples and Q&A sessions with complement the course.

Agenda

  • Day 1
  • Day 2
  • Thursday, 24 October 2019

    9:00
    Welcome


    9:15
    Overview and Introduction into Pre-filled Syringe Market

    • Overview & Trends
    • Stakeholders
    • User's perspective

    10:15
    Technical Aspects

    • Syringe
    • Stopper
    • Plunger
    • Needle
    • Needle shield
    • Autoinjector
    • Regulatory guidelines and technical standards: EU / US / ISO / …

    11:15
    Coffee Break

    11:45
    Overview and Introduction into Drug-syringe Interactions

    • Aggregation
    • Degeneration
    • Oxidation
    • Viscosity
    • (Bubbles)

    12:15
    Lunch Break

    13:15
    Overview and Introduction to Manufacturing Process of PFS

    • Barrel forming
    • Washing
    • Siliconization
    • Sterilization
    • Regulatory guidelines and technical standards: EU / US / ISO / …

    14:15
    Fill and Finish

    • Filling
    • Stoppering
    • Assembly
    • Technical Standards: ISO

    14:45
    Hands-on Session 1


    15:45
    Coffee Break

    16:15
    Hands-on Session 1 (cont.)


    17:15
    Q & A


    17:30
    End of Day 1

  • Friday, 25 October 2019

    9:00
    Recap Day 1


    9:30
    The Syringe (Body) - Example Specification

    • Materials (glass, polymer)
    • Shape
    • Cone
    • Diameter
    • Mechanical properties
    • Chemical Properties
    • Siliconization
    • Impact of different drug properties
    • Dual-chamber syringe
    • Needle shield, tip cap
    • Nest, tub
    • Integrated needles, luer lock adapter, cone types
    • Back stops, rods
    • Regulatory guidelines and technical standards: EU / US / ISO / …

    10:15
    Coffee Break

    10:45
    Plunger Stopper, Needle Shields, Tip Caps

    • Materials
    • Physical properties
    • Chemical properties
    • Washing
    • Siliconization
    • Impact of different drug properties
    • Syringe system functionality
    • Regulatory guidelines and technical standards: EU / US / ISO / …

    11:45
    Manufacturing Aspects Regarding Filling, Finishing and Assembly

    • Bulk versus nested
    • Nest sizes
    • Standard processing for Rod Insertion and Labelling
    • Handling of syringes considering glass to glass vs. no glass to glass contact

    12:30
    Lunch Break

    13:30
    Assembly of Syringes and Administration Devices

    • Pen Injectors
    • Safety Systems
    • Autoinjectors
    • Manual versus

    Design Independent Assembly


    14:30
    Hands-on Session 2


    15:30
    Q & A


    17:30
    End of Course

Trainers

Michael Andersen
Michael Andersen
Bosch Packaging Scandinavia
Christa Jansen-Otten
Christa Jansen-Otten
West
Klaus Ullherr
Klaus Ullherr
Robert Bosch Packaging
Bernd Zeiss
Bernd Zeiss
Gerresheimer Bünde GmbH

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the course participants

    • Know the stakeholders in Pre-fillable and Pre-filled syringes
    • Understand what the packaging supplier can support with and what can only be done at the pharma company  
    • Understand Pre-filled syringe technologies, materials, applications and requirements
    • Are able to develop a syringe system that fits the needs of a dedicated application
    • Are able to compare different syringe types with regard to their advantages and disadvantages.
  • Who Should Attend

    Who Should Attend

    • Packaging engineers with little or no experience in Pre-filled syringes
    • Pharmacists and formulation developers who want to learn about prefilled syringes as a device
    • Quality, Purchasing, Business Development, Sales
  • 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.

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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.

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 the conference 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

* 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 [email protected] 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 [email protected]. Phone messages are not accepted.

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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

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

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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