News Ongoing Process Verification during Lifecycle Training Course
04 October 2019
Kyiv
Course Objectives
• to be acquainted with the scope of FDA, EU and other international validation guidelines
• to highlight the regulatory requirements to trend analysis
• to understand the importance of a statistical process control
• to discuss an example of statistical data analysis
• to perform optimization of process control and quality control
• to unscramble the real meaning of statistical trending of stability data
• to learn tools for ongoing process verification during lifecycle
Target group
Anyone who wants to know more about GMP, such as quality control, quality assurance, and operations staff who perform GMP activities.
Agenda
| 09:30-10:00 | Registration of participants |
| 10:15-12:00 | Regulatory requirements to trend analysis |
| 12.00-13.00 | Example of statistical data analysis |
| 13:00 – 14:00 | Lunch break |
| 14:00 –15:45 | Optimization of process control and quality control |
16:00 -17:30 |
Ongoing Process Verification during Lifecycle |
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