Training Course Syllabus:

Pharmaceutical Quality Risk Management (QRM) Overview

Objectives of the Presentation

Understand the key points of US requirements, citations and expectations that may influence the implementation of a QRM process
Learn how to implement a risk decision tree and the appropriate use of risk assessment tools
Identify specific strategies for defining the criteria for risk ratings and risk mitigation requirements
Know how to apply risk management methodologies throughout the product lifecycle
Understand how risk assessments align with the overall implementation of a robust QRM system that is applicable for the product lifecycle
Understand best practices and lessons learned from implementing QRM and how to facilitate effective risk assessmentsv
Outline a Quality Risk Management Plan enabled by an understanding and the application of a lifecycle-based QRM process, inclusive of risk ranking

Why Should you Attend

Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, explain the level of risk based on severity, occurrence, and detect ability and how the QRM process is used to make decisions. In addition they will be able to identify key QRM terminology and recognize the four (4) key components of Quality Risk Management. Finally they will have a strong understanding of the key concepts associated with the risk management, risk tools and their application.

Who will Benefit

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: Senior quality managers, Quality professionals, Regulatory professionals, Compliance professionals, Production supervisors, Manufacturing engineers, Production engineers, Process owners, Quality engineers, Quality auditors, Development professionals, Senior development managers, Risk Management, Quality assurance/control, Project engineers and managers, commissioning, validation, engineering and service providers, Manufacturing operations and facilities professionals

Seminar Summary:

Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization. There is much confusion on how to define risk and individuals often think of quality risk management as just a tool like FMEA analysis verses an overall QRM approach. This training will explain the important concepts associated with a QRM approach. (see full course description)

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