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Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.
There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

Course Details

Ojectives

  • Review fundamental concepts and statistical tools related to process performance and process control, such as data collection, data analysis, and process capability.
  • Recognize the documentation that is relevant to process-focused audits.
  • Command top management’s attention by adding strategic value to your auditing process.
  • Recognize the benefits of applying process design and process improvement methodologies that lead to continual improvement and business sustainability over the long term.
  • Understand key financial indicators and how they can be linked to process metrics.
  • Understand effectiveness-focused auditing methodologies and evidence gathering.
  • Explain methods for measuring the effectiveness and efficiency of the MS auditing program and its value.
  • Recognize how an audit program can bring value to the organization and how to measure the return on investment.

Topics

  • Process performance variables and how to measure them
  • Interpreting process maps and identifying opportunities for improvement
  • Statistical tools that are relevant to successful process auditing (e.g., process capability and statistical process control)
  • Breakthrough audit planning, including:
    • Process-focused, risk-based audit scheduling
    • Process and results data and documentation needed to plan audits and determine audit trails
  • Breakthrough on-site audit activities, including:
    • Special process auditing
    • Handling adverse audit conditions
    • Measuring audit program effectiveness
    • Reporting nonconformities

Who Should Attend

Aimed at experienced MS auditors who have successfully completed an auditing course and performed actual audits, as well as audit program managers and QMS management representatives.

  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs

    4

Virtual Session Details

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Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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