ICH Q10: How to manage your Quality System including Quality KPIs - EU edition MasterClass
12-13 December, 2022
This MasterClass is completed by fundamentals of an appropriate Quality Culture which constitute the basis for a successful PQS - besides all regulations.
The ICH Q10 guideline - Pharmaceutical Quality System (PQS) - is one of the most important international regulations adopted by major regulatory bodies such as FDA, EMA, and others being cited in countless audit observations. The Master Class is completed by fundamentals of an appropriate Quality Culture which constitute the basis for a successful PQS.
12-13 December, 2022 , Virtual
Time Zone: UTC/GMT+1 /CET
Besides the theoretical and regulatory aspects of ICH Q10 and related PQS matters, a company has to implement a viable and meaningful process to govern and control its PQS. This is the focus of the second major topic of this Master Class: establishing meaningful Quality Key Performance Indicators (KPIs). You will learn all aspects to consider when implementing ICH Q10 properly in your organization as well as a useful technique to elaborate its meaningful steering indicators based on practical examples.
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Who should attend?
• Site leadership representatives („Sr. Management“)
• Continuous improvement representatives
• Quality assurance representatives
• Quality Control staff and managers
• Manufacturing representatives
• Engineers and Facility Management representatives
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Manager, Senior Investigator
MT Sword Laboratories (BMS)
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