2018 PDA Container Closure Integrity Testing Training Course - Taiwan
Registration Options
Individual Registration
Group Registration
The PDA Container Closure Integrity Testing Training Course utilizes lectures, instrument demonstrations, hands-on testing exercises, case studies, and interactive group discussions to provide insight into the fast-evolving regulatory landscape in the container closure integrity field and the latest development in testing technologies. The Course introduces a practical and meaningful methodology to construct package integrity profiles using a risk-based approach and appropriate Container Closure Integrity (CCI) testing methods.
Key topics include:
- Up-to-date regulatory and pharmacopeia requirements on CCI
- CCI requirements for various container and drug product types using a risk-based approach
- Principles of various CCI testing techniques and their practical applications
- Testing method selection for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles
- CCI testing method development, validation approach and best practices
- Common issues and pitfalls in CCI testing applications
The Course provides on-site instrument demonstrations and hand-on testing experience of various advanced CCI testing techniques, including vacuum decay, electrical conductivity and capacitance, laser-based gas headspace analysis, and mass extraction leak test. In addition, participants can take advantage of the breakout sessions to discuss topics of interest with testing experts from major instrument vendors, such as PTI, ATC, and Lighthouse.
Who Should Attend
Parenteral drug packaging engineers and formulation scientists; Laboratory scientific staff and managers; Parenteral manufacturing Staff; Sterility Quality Assurance; Regulatory affair scientists; CMC Project Management; Pharmaceutical packaging component manufacturing staff
Contact
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More information coming soon.
Day 1
Thursday,8-November
8:00 – 17:30 | Registration Open
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9:00 – 10:30 |
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9:00 | Welcome and Introduction
9:30 | Regulatory Requirements and CCI Assurance
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10:30 – 11:00 | Refreshment Break
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11:00 – 12:00 |
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11:00 | CCI Test Methods: Fundamentals and Overview
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12:00 – 13:00 | Networking Luncheon
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13:00 – 15:30 |
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13:00 | CCI Test Methods: Fundamentals and Overview
14:00 | CCI Test Technologies
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15:00 – 15:30 | Refreshment Break
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15:30 – 17:00 |
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15:30 | CCI testing technologies
16:30 | Group Exercise #1
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Friday, 9-November
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9:00 – 10:30 |
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9:00 | Invited Lectures
9:45 | Hands-on training
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10:30 – 11:00 | Refreshment Break
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11:00 – 12:30 |
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11:00 | Invited Lectures
11:45 | Hands-on Training
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12:30 – 13:30 | Networking Luncheon
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13:30 – 14:30 |
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13:30 | Method Development and Validation
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14:30 – 15:00 | Refreshment Break
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15:00 – 16:30 |
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15:00 | Approaches to CCI Testing Method Selection
15:30 | Group Exercise #2
16:00 | Class Discussion
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Regent Taipei
Taipei, Taiwan ,
- Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company
- Jaime Cobo Vélez, Sales and Marketing Director, Wilco AG
- Evan Davis, Product Line Manager, LIGHTHOUSE Instrument
- Heinz Wolf, General Manager, PTI
- Allen Sheng, MD, Managing Director, Shanghai Zillion M&E Equipment Co., Ltd
- Dong-Oh Kwon, Managing Director, GIS Korea Ltd.
- Young Jun Kwon, GIS Korea Ltd.