Drug Quality Risk Management


8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 10:15 a.m.

Workshop Introduction and Objectives: Quality Risk Management (QRM) Defined

  • The what and why behind QRM
  • The basic elements of QRM
  • Analysis of all available information
  • Determine the likelihood of a risk
  • Assess the risk using methods to determine potential impact and severity
  • Evaluate and decide which risks to control
  • Control and mitigate the significant risks
  • Monitor
  • Communicate with all stakeholders
  • INTERACTIVE EXERCISE Exchange ideas with colleagues about why risk is so important within the pharmaceutical industry and discover various perspectives and ideas in this “two-minute talk.”
  • How have recent events shaped our thinking of risk management?

10:15 a.m. – 10:30 a.m.


10:30 a.m. – 11:00 a.m.

The Evolution of Quality Thinking

  • The movement from specifications and testing to process understanding
  • Changes in GMP requirements and expectations related to QRM
  • Exploring quality by design to gain the knowledge of how the process reduces risks
  • QRM and regulatory harmonization — recent ICH guidelines that discuss risk management: ICH Q8, Q9, and Q10
  • FDA’s new draft validation guideline: how it incorporates risk-based thinking
  • The growing importance of needing to have product and process understanding
  • Recent FDA warning letters concerning risk assessment and process understanding
  • ISO-31000:2009 — the international standard for risk management


11:00 a.m. – 12:00 p.m.

Key Concepts and How They Apply to Risk- Based Thinking

  • Discuss how the vulnerabilities of a product or process may make it more susceptible to hazards
  • Learn the expanded and working definitions of what a hazard is as applied to QRM for the pharmaceutical industry
  • Understand and integrate the 4 types of recognized ICH risks into your risk assessment

12:00 p.m. – 1:00 p.m.


1:00 p.m. – 2:30 p.m.

How We Think About Risk

  • INTERACTIVE EXERCISE Risk perceptions — re-creating an important study that showed how perceptions affect how we as people perceive and react to risks.
  • Who should think about risk?
  • Who should be involved in the firm’s risk management process?
  • Where does quality risk management apply within the pharmaceutical industry?
  • Accident theory: the basis for many risk assessment tools
  • Historical and current models used to describe how accidents (and  incidents) occur
  • How accident models can be used in a predictive way

2:30 p.m. – 2:45 p.m.


2:45 p.m. – 4:30 p.m.

The QRM Process: What It Is All About

  • Defining each task, what is accomplished and how it is done
  • Preliminary tasks: Coming up with the risk question
  • Define the system or process
  • Identify the hazards
  • Assess the risks
  • Evaluate the risks
  • Control and mitigate the significant risks
  • Monitor
  • Communicate to stakeholders
  • INTERACTIVE EXERCISE How can you apply the quality risk management process?
  • The risks of too much and too little documentation during the QRM process
  • The risk assessment toolset: a look at some of the tools used in risk assessment and their origin
  • Risk ranking
  • Preliminary risk assessment
  • Hazard and operability studies (HAZOP)
  • Hazard analysis and critical control points (HACCP)
  • Failure mode effects and criticality analysis (FMECA)
  • Fault tree analysis (FTA)
  • Event tree analysis (ETA)

4:30 p.m.

Session Wrap-up



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