2018 PDA Development of a Pharmaceutical Product in an Injection Device Training Course - Taiwan

Taipei, Taiwan
Ask a Question

The 2018 PDA Development of a Pharmaceutical Product in an Injection Device 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.

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.

Contact

Program Inquiries
Training Course Inquiries
Registration Customer Care

More information coming soon.

Day 1

Thursday, November 8

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.

Regent Taipei


Taipei, Taiwan ,
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