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2020 ParPack

Container Closure Development

Feb 27, 2020
Basel, Switzerland

This one-day training course will cover the relevant issues of container closure development.

  • Education
  • Europe

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Overview

The course will give an overview on how to develop a container closure system for parenteral products. Starting with setting up of a product profile of the final product container, all aspects will be covered like selection of materials, assessment of container closure systems, specification and documentation of components and entire systems. In addition, current hot topics such as glass delamination and container closure integrity testing will be discussed.

For all topics of the agenda presentations will be given. The participants are invited to add own experience, ask questions and offer issues to be discussed within the group and/or with the trainer. The intention is to work in an open workshop-like atmosphere.

Agenda

  • Thursday, 27 February 2020

    9:00
    Welcome & Introduction


    9:30
    Definitions

    • Compendial definition
    • Functional definition
    • Components vs CCS
    • Description of options
    • Materials

    9:45
    Regulatory Background

    • Ph.Eur.
    • USP
    • JP
    • FDA Guideline
    • EU Directive
    • Relevant eCTD sections

    10:45
    Coffee Break

    11:15
    Development of Container Closure Systems

    • Set-up of target profile
    • Packaging materials
    • Modification of materials
    • Extractables & Leachables (E&L) testing
    • Permeability
    • Light transmission
    • Processability
    • Functional testing
    • Container closure integrity (CCI)
    • Shipping assessment
    • Combination products

    12:30
    Lunch Break


    13:30
    Workshop: Develop Your CCS


    15:00
    Coffee Break


    15:30
    Presentation of Workshop Results


    16:00
    Setting of Specifications / Submission Documentation

    • Technical/ Quality specification
    • Regulatory specification
    • Technical drawing
    • Regulatory drawing
    • DMF for US submission

    16:30
    Wrap-up and Final Q&A


    17:00
    End of Course

Trainers

Jörg Zürcher
Jörg Zürcher
Bayer HealthCare

Additional Information

  • Learning Objectives

    Learning Objectives

    • Set-up of a target product profile of a container closure system
    • Select appropriate container closure materials, components, and systems
    • Apply the appropriate regulations and standards to container closure systems for parenteral formulations
    • Prepare a development plan of a container closure systems from the early development until market phase
    • Specify container closure system regarding technical aspects and regulatory requirements
    • Understand compendial requirements and quality as well as technical standards regarding container closure components and systems
  • Who Should Attend

    Who Should Attend

    • Scientists in Drug Product Development
    • Scientists/ Engineers in Packaging Development
    • Regulatory Affairs Experts
  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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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.

Congress Center Basel

Messepl. 21
Basel, Switzerland
Phone: +41 58 206 28 28

Congress Center Basel
  • Accommodations
    Hotels Nearby

    PDA Europe recommends the reservation at one of the following hotels.
    The general terms of business are valid at the event hotels.


    Pullman Basel Europe
    Clarastrasse 43
    4058 Basel
    Switzerland
    Tel: +41616908080

    The Pullman Basel Europe is a vibrant and outstanding upscale hotel within walking distance of the old town, the Rhine river and only 200 m from the Congress Center Basel (Messe). Apart from the fashionable and luxuriously appointed rooms, the modern Fit Lounge and a charming bistro with regional cuisine, it also boasts a green inner courtyard to relax.

    The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card.

    PDA Europe has reserved a limited number of rooms until the 06th January 2020

    • Single Superior Room CHF 220 per night*
    • Double Superior Room CHF 240 per night*

    You can book your Hotel Accomodation here!

    *Rates are per room and night, including the following services and benefits:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply

    Swissôtel Basel
    Messeplatz 25
    4005 Basel
    Switzerland
    Telephone : +41 61 555 3333
    [email protected]

    The Swissôtel Basel (4**** superior) offers elegant guest rooms and real Swiss hospitality for an authentic Alpine experience. The rooms boast hand-picked, unique furnishings and calming tones with splashes of vibrant yellow. In-room technology, WiFi, workspaces and entertainment centres are complemented with Italian coffee machines and quality en-suite amenities to help you get the most out of your stay.

    It is centrally located directly connected with the Congress Center Basel (Messe) and within walking distance of the old town, the Rhine River and numerous sight-seeing spots.

    The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card.

    PDA Europe has reserved a limited number of rooms until the 06th January 2020

    • Single Superior Room CHF 255 per night*
    • Double Superior Room CHF 285 per night*

    You can book your Hotel Accomodation here!

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

How to Get Here

By Air

Pullman Basel Europe:

Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the hotel. A direct bus (Line Nr. 50) runs every 20 minutes A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station. A taxi takes approximately 10-20 minutes to the hotel.


Swissôtel Basel

Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the hotel. A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station. A taxi takes approximately 10-20 minutes to the hotel.

By Car

Swissôtel Basel

Exit ‘Basel Nord/Kleinhüningen’ from Hwy A5 or exit ‘Badischer Bahnhof/Basel Ost’ from Hwy A35. Self-parking or valet parking is available at the car park of the fairgrounds (allowed maximum height of 2m).

Other Options

Pullman Basel Europe
Rail:

  • The main train station ‘SBB Basel’ is approximately 2km away: take the tram No. 16 Bhfeingang Gundeldingen to Clarastrasse (duration 15-17 minutes, departure every X minutes)
  • the train station ‘Basel Badischer Bahnhof’ is approximately 1km away: take the tram No. 6 or No. 16 to Clarastrasse (duration 4 minutes, departure every 8 minutes)

Swissôtel Basel
Rail:

  • The main train station ‘SBB Basel’ is approximately 2km away: take the tram Nr. 1 or Nr. 2 to Messeplatz Basel
  • the train station ‘Basel Badischer Bahnhof’ is approximately 1km away: take the tram Nr. 6 to Messeplatz Basel

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €895

All fees given in Euro and excluding VAT (7,7%)

* 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.

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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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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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