Introduction to Risk-based thinking and Quality Risk Management

Course Goal:

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

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 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 rating 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
• Hazard Identification Tool (HIT)
• Preliminary Risk Analysis (PRA)
• Risk Check Sheets
• Failure Mode Effects Analysis (FMEA)
• Hazard Analysis and Critical Control Points (HACCP)

Who should attend

Those in management, quality, development, compliance, laboratory, operations, and other technical areas. Also, those who will participate in QRM teams and prospective QRM facilitators.