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    FDA Q9(R1) Quality Risk Management Training

    Risk Management (2)-2

    One Course covering all of the recommended Risk Management Techniques

    On May 3, 2023, the FDA adopted the International Council for Harmonization’s (ICH) revised guideline for quality risk management. It was released as a Guidance Document that advises pharma companies on risk management methodology, risk-based decision-making, and managing subjectivity. And it recommends the use of eight Risk Management Techniques.

    The guidance document, entitled “Q9(R1) Quality Risk Management,” was prepared under the auspices of the ICH. It is a revision of the 2006 guidance for industry and addresses…

    • product availability risks due to manufacturing quality issues,
    • lack of understanding as to what constitutes formality in Quality Risk Management (QRM) work,
    • lack of clarity on risk-based decision-making and
    • high levels of subjectivity in risk assessments and QRM outputs.

    The revision is intended to provide guidance on quality risk management principles and tools that can be applied to different aspects of pharmaceutical quality.

    Suggested Quality Risk Management Methods and Tools

    Annex I lists recommended Quality Risk Management Methods and Tools, namely,

    • Basic Risk Management Facilitation Methods
    • Failure Mode Effects Analysis (FMEA)
    • Failure Mode, Effects, and Criticality Analysis (FMECA)
    • Fault Tree Analysis (FTA)
    • Hazard Analysis and Critical Control Points (HACCP)
    • Hazard Operability Analysis (HAZOP)
    • Preliminary Hazard Analysis (PHA)
    • Risk Ranking and Filtering

    A general description is given of each tool and suggested areas of use. But no more.

    deGRANDSON Global Course ‘Risk Management Techniques – Foundation’

    This Course includes all of the risk management tools mentioned in Annex I.

    After a Module on the Risk Management Process and the various terms used (and abused) regarding risk, each tool is described in detail as….

    • Background and Use
    • Inputs
    • Process
    • Outputs
    • Strengths and Limitations
    • Examples

    This is the level of detail needed to implement these tools effectively.

    If you would like full details, please click on the button below.

    View the ISO 31010 Risk Management - Foundation Course

    We have three Risk Management Courses being readied for launch. These are...

    You can visit our Risk Management Courses page for full details of the various Courses available if you'd like.

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    deGRANDSON Global is an ISO Certified Educational Organization

    New call-to-actionIn October 2021, we secured certification to three education-related ISO Standards.  We now have a university-grade management system in place conforming to the requirements of  …

    • ISO 21001, Educational Organizational Management System,
    • ISO 29993, Learning Services outside formal Education,  and
    • ISO 29994, Learning Services – additional requirements for Distance Learning.

    We have chosen ISO 21001 certification because it is based on independent third-party assessment, unlike IRCA and Exemplar badges (which we believe are commercially compromised).  It is a ‘university grade’ standard globally by schools, colleges, and universities to demonstrate competence.


    Written by Dr John FitzGerald

    Director & Founder of deGRANDSON Global. Spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems
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