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Parenteral Drug Association Connecting People, Science and Regulation ®

Container Closure Development

Mar 01 - Mar 01, 2018 |
Mar 01, 2018 |
Marriott Park Hotel Rome | Rome, Italy
  • Education
  • Europe
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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.

Who should attend?

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

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

Instructor

Jörg Zürcher, Senior Scientist, Bayer
Jörg Zürcher is a pharmacist by education. After his studies and PhD thesis at the Free University in Berlin, he started his career in the pharmaceutical industry 1990 with the former Schering AG. He is responsible for the development of container closure systems and application devices at Bayer HealthCare and has more than 25 years’ experience in that field. His current focus is the development of systems/devices for liquid and parenteral as well as ophthalmic dosage forms.

Thursday,1 March 2018

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 Training Course

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

845 Euro

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

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Exterior

Marriott Park Hotel Rome
Via Colonnello Tommaso Masala 54
00148 Rome
Italy
Tel: +39-06-658821
Hotel Website

The Rome Marriott Park Hotel offers an uncommon blend of convenience and sophistication. With an outstanding location just minutes from Rome's Fiumicino Airport and a vast selection of top-quality amenities, our hotel sets the stage for a remarkable experience in the Eternal City.

Thoughtfully designed hotel rooms feature handcrafted furniture and elegant marble bathrooms, in addition to modern comforts such as a flat-screen TV. We're one of Rome's premier venues for any business meeting or event, with an astonishing 126,971 square feet of adaptable space and an expert planning staff. Satisfy your cravings here in Rome with delicious on-site dining, or take a leisurely swim in our seasonal outdoor pool.

Our well-placed hotel is only 10 miles from Fiumicino Airport and from world-renowned destinations, including Vatican City and the Colosseum. For added convenience, a shuttle service to and from central Rome is available.

PDA Europe has reserved a limited number of rooms until the 19th December 2017.
Book your room for the PDA Group Rate.

Single Room € 100 per night*
Double Room € 120 per night*

*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 Charge will apply

How to Get There

Fiumicino Airport – FCO
Airport Phone: +39 06 65951

Hotel direction: 10.2 miles NE
Airport shuttle service, scheduled, fee: 5 EUR (one way)

Parking

  • On-site parking, fee: 4 EUR hourly, 12 EUR daily

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4049

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