Quality Risk Management Training - Pharmaceuticals 01 (PQRM01)
This in depth one day course is outlines the key concepts contained in ICH Q9 and ATSM 2500E and how to apply the standard / guideline to pharmaceutical manufacturing.
For example;
- Quality Assurance personnel
- Quality Control personnel
- Operations and Manufacturing personnel
- Validation personnel
"...the importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system."
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE - QUALITY RISK MANAGEMENT Q9 November 2005
Learning Objectives and Course Description
This course includes:
- understand the basics of Quality Risk Management
- awareness of techniques such as PHA, FEMA, HACCP
- understand the basics of applying effective Quality Risk Management mechanisms
- contribute and add value to the Quality Risk Management process
- understand Risk Based compliance, risk based decisions and focus efforts on the greatest risks to patient safety and product quality
- receive tuition in basic Risk modelling
- prioritise workloads according to risk management
- risk reduction and mitigation strategies that actually achieve their purpose
- understand how knowledge of your product and processes can lead to profitability
This one day course is intended to provide participants with a working knowledge (illustrated by recent examples) and understanding of the current cGMP.
Benefits include
- learning from experienced professional trainers
- understanding Risk Management and its applications for shop floor personnel
- one on one tuition during the course as the classes and are small and intimate
- receipt of a complete training kit, trainer's notes and a certificate of completion for participants assessed.
View schedule and how to make a booking.
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