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PDA Primary Packaging and Devices for Biopharmaceuticals Training Course

Apr 19 - Apr 19, 2018 |
Apr 19, 2018 |
Imperial Palace Seoul | Seoul, Korea
  • Education
  • Asia-Pacific
  • Western Hemisphere Events
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The PDA Primary Packaging and Devices for Biopharmaceuticals Training Course gives an introductory overview of container closure development and devices. This includes primary packaging components devices, test methods like silicon oil testing for cartridges and syringes, visual inspection and particle analysis, mechanical properties of containers and suitability tests needed for the assembly into devices. Development strategies and regulatory requirements will be addressed as well.

Small groups will have hands-on activities with test equipment and samples of components and devices. Intense discussions with the subject matter experts will be possible throughout the course. Questions can be sent in advance to roessling@pda.org.

Who Should Attend

Individuals working in development, manufacturing, engineering QA and QC functions, especially those dealing with container and device development but also audit functions and suppliers.

Download Agenda

Thursday, April 19

8:00 – 17:30 | Registration Open

9:00 – 10:30

9:00 | Welcome and Introduction
Instructor: Thomas Schoenknecht, PhD, Executive Director, Business Development, SHL Group AB

9:45 | Primary Packaging in Glass
Instructor: Alessandro Morandotti, Product Manager, Ompi

  • Glass: Manufacturing and forming of containers
  • Phys. & chem. Properties
  • Quality Aspects
  • Bulk and ready to use concepts

10:30 – 11:00 | Refreshment Break

11:00 – 12:30

11:00 | Primary Packaging in Glass: Pre-Filled Syringes for Biopharmaceuticals
Instructor: Sébastien Jouffray, BD

  • Considerations in selection of delivery systems
  • Ensuring drug/container compatibility
  • Ensuring container/device integration and performance
  • Partnering for success

11:45 | Elastomeric Packaging Components in a Container Closure System
Instructor: Tan Shi Min, West

  • Material, Stopper Manufacturing Processes and Controls, Considerations in Selecting a Packaging Component, Formulation, Design, Lamination, Finishing & Packaging, Considerations for Testing

12:30 – 13:30 | Networking Luncheon

13:30 – 14:45

13:30 | Devices
Instructor: Thomas Schoenknecht, PhD, Executive Director, Business Development, SHL Group AB

  • Pens and autoinjectors
  • Functions and use

14:00 | Test Methods of Syringes and Devices
Instructor: Erik Berndt, Industry Manager, Medical/Pharmaceutical, Zwick GmbH & Co KG

  • Test methods according to ISO 11040 and 11608
    • Breakage test of container
    • Device assembly tests

14:45 – 15:15  | Refreshment Break

15:15 – 18:00

15:15 | Hands-On Exercises with Components and Test Equipment

17:00 | Regulatory Aspects of Combination Products
Instructor: Thomas Schoenknecht, PhD, Executive Director, Business Development, SHL Group AB

17:30 | Q&A and Discussion

Standard

Member

$495

Nonmember

$675

Government/Health Authority/Academic

Member

$315

Nonmember*

$315

Student Member

Member

$200

Nonmember*

$250

Young Professional Member †

Member

$270

Contact

Molly O'Neill Moir, CMP
Vice President, Programs & Meetings
Tel: (301) 656-5900 ext. 132
Email: moir@pda.org

All rates in US Dollars.

*For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to take advantage of this rate.

REFUND FOR COURSES: If your written request is received by March 30, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

Thomas Schönknecht, PhD, Executive Director, Business Development, SHL Group AB
Erik Berndt, Industry Manager, Medical/Pharmaceutical, Zwick GmbH & Co KG
Alessandro Morandotti, Product Manager, Ompi
Sébastien Jouffray, BD
Tan Shi Min, West
More information coming soon.
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https://store.pda.org/Meetings/Login.aspx?ID=4233
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