Quality Risk Management

Applying the principles and tools

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

Course description

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.

Course content

  • 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

Learning objectives:

  • Provide a working knowledge of the concepts and tools used in managing risk with applications to pharma and biopharma
  • Develop rating scales that can more objectively describe severity, occurrence, and detectability.
  • 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.

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Date & Time
2 days
IndustryPharmaceuticals
LanguageEnglish
LevelBasic
RegionEU/US

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In-House Training

This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.

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