How to implement a risk decision tree and the appropriate use of risk assessment tools
The key points of US requirements, citations and expectations that may influence the implementation of a QRM process
How to apply risk management methodologies throughout the product lifecycle
Identify specific strategies for defining the criteria for risk ratings and risk mitigation requirements
Best practices and lessons learned from implementing QRM and how to facilitate effective risk assessmentsv
How risk assessments align with the overall implementation of a robust QRM system that is applicable for the product lifecycle
Outline a Quality Risk Management Plan enabled by an understanding and the application of a lifecycle-based QRM process, inclusive of risk ranking
Who should Attend
Senior quality managers
This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. In addition other related industries will benefit. Following personnel will benefit from the course:
Regulatory professionals
Quality professionals
Production supervisors
Compliance professionals
Production engineers
Manufacturing engineers
Quality engineers
Process owners
Development professionals
Quality auditors
Risk Management
Senior development managers
Project engineers and managers, commissioning, validation, engineering and service providers
Quality assurance/control
Manufacturing operations and facilities professionals
