2018 PDA Development of a Pharmaceutical Product in an Injection Device Training Course - Taiwan
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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.
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Day 1
Thursday, November 8
8:00 – 17:30 | Registration Open
9:00 – 10:30 |
9:00 | Welcome and Introduction 9:45 | Primary Packaging in Glass
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10:30 – 11:00 | Refreshment Break
11:00 – 12:30 |
11:00 | Primary Packaging in Glass: Pre-Filled Syringes for Biopharmaceuticals
11:45 | Elastomeric Packaging Components in a Container Closure System
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12:30 – 13:30 | Networking Luncheon
13:30 – 14:45 |
13:30 | Devices
14:00 | Test Methods of Syringes and Devices
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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 |
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Regent Taipei
Taipei, Taiwan ,
Erik Berndt, Industry Manager, Medical/Pharmaceutical, Zwick GmbH & Co KG
Alessandro Morandotti, Product Manager, Ompi
Sébastien Jouffray,BD
Tan Shi Min, West