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Day One(6/11/2012) |
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9:00~10:30 |
New GMP certification and the application of the new standard |
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10:30~11:00 |
Coffee break and Networking |
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11:00~11:45 |
Analyzing current quality management system situation of drug manufacturers and improvement approaches |
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11:45~12:30 |
Validation Plan and Implementation of New GMP Practice |
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12:30~14:00 |
Luncheon and Networking |
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14:00~14:45 |
Implementation experience of New GMP and specific measures of quality management system |
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14:45~15:30 |
How to build a robust quality system for pharmaceutical product? |
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15:30~15:45 |
Coffee break and networking |
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15:45~16:30 |
Understanding manufacturing deviation and the implementation of corrective action and preventive action (CAPA) |
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16:30~17:00 |
Case study: document management challenges under the requirement of new GMP |
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17:00~17:30 |
Panel Discussion: Optimizing drug production quality management system through
multi-sectoral cooperation |
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Track A: featuring sterile drug products |
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9:00~10:00 |
New GMP risk control requirements of sterile drug products and manufacturing process verification design |
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10:00~10:45 |
Understanding process requirements and verification of small volume injection production equipment |
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10:45~11: 00 |
Coffee Break and Networking |
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10:45~11:40 |
New GMP requirement for freeze drying manufacturing and improvement |
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11:40~12:10 |
Panel discussion: Real-life pharma manufacturers’ experience on passing new GMP compliance sterile drug products inspection |
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12:15~14:00 |
Luncheon and Networking |
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14:00~14:45 |
Concrete operations: how to build GMP compliance clean public system |
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14:45~15:30 |
Investigating sterile drug production verification and pollutant risk control |
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15:30~15:45 |
Coffee Break and Networking |
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15:45-16:30 |
Identifying key points of sterile drug products inspection |
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16:30~17:15 |
Investigating sterile drug production verification and microorganism risk control |
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Track B: API |
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9:00~9:45 |
Fully Understanding regulatory expectation of cGMP and inspectorss’ inspection priorities based on new regulatory climate |
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9:45~10:30 |
Highlighting the content of ICH-Q11 and its influence on API industry in China |
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10:30~10: 45 |
Coffee Break and Networking |
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10:45~11:30 |
Quality, cost, speed---three key factors to promote API export for Chinese API manufacturers |
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11:30~12:15 |
Panel discussion: Real-life API manufacturers’ experience on passing new GMP inspection |
For speaking opportunities, please contact
Ms. April Pan
Conference Producer
Email: april.pan@ubm.com
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