PDA Primary Packaging and Devices for Biopharmaceuticals Training Course

Seoul, Korea
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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.

More information coming soon.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.

Day 1

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
Agenda is subject to change.

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.

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