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Life Sciences Risk Management A to Z - Best Practices for Effectiveness and Efficiency
Quality Risk Management is now at the cutting edge of the life sciences industry internationally. ICH Q9 Guideline on Quality Risk Management (QRM) was incorporated in GMP by the MHRA, PIC/S and the EMEA.
Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS). Pharmaceutical professionals should be able to use risk management techniques and tools based on ICHQ9 to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System.
This highly interactive course consists of a lively mix of presentations, group exercises and discussions to provide an in-depth understanding of Quality Risk Management and know-how to be able to implement Quality Risk Management in the work place.
General principles and approach to risk management
Regulatory requirements for application of risk principles
Key steps and activities for a risk management program
How compliance and risk management are strategically used
Principles and requirements of ICH Q9
How to classify cGMP non-conformances according to risk priority
Hazard Analysis and Critical Control Point (HACCP) in production and process control
Who Will Benefit:
The course is designed to service a wide range of participants from various disciplines within the pharmaceutical and medical device industry. Typically participants will be managers or supervisors who have experiences in a GMP related environment and need QRM to perform in their current position.
Use coupon code NB5SQH8N and get 10% off on registration.
There may be many networking opportunities at the Life Sciences Risk Management A to Z - Best Practices for Effectiveness and Efficiency. Find out more in the event details below.
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