Quality Risk Management:
Applying the principles and tools

Risk Assessment and Risk Management are growing in importance. Here’s a course that helps those involved with making risk-based decisions!

Industry field:

Pharmaceutical and Biopharmaceutical industry

Course description:

What is risk?
How does an organization identify and reduce it?

Regulatory agencies world-wide are encouraging our industry to identify, assess, and manage the potential quality risks associated with pharmaceutical and biotech products.  Pharmaceutical firms are also realizing that risk management is an important way to rationally set priorities for quality and compliance activities. 

This two-day workshop presents the concepts of risk assessment and risk management to executives, managers, and technical personnel.  Using examples and activities, participants learn about seven of the most frequently used tools and processes for identifying and quantifying risk.  Integrated approaches to prevent risks from being expressed and protecting things of value are also presented.

Tools discussed include:

• Holographic Hierarchical Modeling and Risk Filtering and Ranking

• Preliminary Risk Analysis

• Hazard Analysis and Critical Control Points

• HazOp

• Failure Mode Effects and Criticality Analysis

• Fault Tree Analysis

• Event Tree Analysis

Course outline:

1. Workshop Introduction and Objectives: participant goals/topics of importance

2. Quality Risk Management (QRM) defined

3. The evolution of "Quality Thinking" in the pharma industry

4. Key concepts and how they apply to risk-based thinking

5. How people think about risk

6. The QRM process: what it is all about

7. Applying Quality Risk Assessment Tools

8. Integrating QRM into your organization

      » Detailed outline

Learning objectives:

Provide a working knowledge of the concepts and tools used in managing risk with applications to pharma and biopharma activities.

Objectives:

• Define terms and concepts important in risk management.

• Describe the importance of risk assessment and risk management to various industries or endeavors.

• Identify and discuss models used to describe accidents.

• Describe the phases used in managing risks.

• Describe techniques used in risk assessment, when they are used, and how they are performed.

• Given a set of quality system elements, identify where risk assessment tools and risk management processes can be effectively used.

• Identify issues in implementing Risk Management in an organization.

Who should attend:

Those in management, quality, development, compliance,
laboratory, operations, and other technical areas.

Course facts

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