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PDA Primary Packaging and Devices for Biopharmaceuticals Training Course

Apr 19, 2018
Seoul, Korea

  • Education
  • Asia-Pacific
  • The Americas
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Overview

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 roe[email protected].

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.

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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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    More information coming soon.

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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.

Imperial Palace Seoul

640 Eonju-ro, Nonhyeon-dong, Gangnam-gu
Seoul, Korea

How to Get Here

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Directions

Registration Fees

Regular Price

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: [email protected]

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 [email protected] or +1 (301) 656-5900.

* For this member type or discount, online registration is not available, please contact [email protected].

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 [email protected].

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