Introduction to Risk Assessment and Risk Management

Course description:

Overview Risk assessment is currently one of the most frequently discussed topics in the pharma and biopharma industries. Is your firm ready to apply these concepts as you develop new products or improve your processes?

This workshop-styled cGMP training course is for pharmaceutical / biotech / biologicals industry personnel who would be involved in applying the concepts and techniques of risk management.
The use of risk assessment and risk management will be examined in regards to process development, operations, and changes. Techniques such as:

• Hazard Analysis and Critical Control Points (HACCP)
• Failure Mode Effects Analysis (FMEA)
• Fault Tree Analysis (FTA)
• Event Tree Analysis (ETA)

will be discussed and used.

Learning objectives

At the completion of this workshop the participant will be able to:

• Define risk assessment, risk evaluation, and risk management.
• Discuss the current importance of risk assessment and risk management in the pharmaceutical and biopharma industry.
• Describe the risk management process, Hazard Analysis and Critical Control Points (HACCP), when it is used, and how it is performed.
• Describe risk assessment techniques, such as Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), when they are used, and how they are performed.
• Discuss how risks are evaluated.
• Discuss how risks are controlled or mitigated.
• Identify examples of organizational structures and systems that can help or hinder a program of risk assessment and risk management.
• Given a process or product, identify and apply the appropriate technique.

Who should attend

Quality, development, operations, and laboratory staff and managers in organizations that must adhere to drug, blood, or biological GMP regulations.