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2019 ParPack

Test Methods for Pre-filled Syringe Systems - Spring Edition

Mar 21 - Mar 22, 2019
Venice, Italy

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, 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
  • 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

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.

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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.

Hilton Molino Stucky Venice

Giudecca, 810
Venice, Italy
Phone: +39 041 272 3311

Make a Reservation
Hilton Molino Stucky Venice
  • Accommodations

    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
  • Amenities

How to Get Here

By Air

Nearest Airport: Venice Marco Polo Airport – VCE

Airport Phone: +39 041 260 9260

By Car

Transfer per Public Boat to the Conference Venue
Distance: 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)

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

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

* 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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Contact

Program Inquiries
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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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