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4 thoughts on “Mastering Risks and Opportunities in GxP: Tips, Tools & Techniques”

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    Honest gap analysis and risk assessment of system, facility ,process, product, equipment etc.

    It’s my personal observation that we r forced by management to reduce RPN value..and accept the risk instead to doing actual risk assessment and mitigation plan.

    By considering the cost required depends on risk mitigation, management asking to change and modify risk assessment.

    Risk assessment and gap asseseny required systematic approach.like brainstorming with team.
    Capturing of various option/alternatives/ etc.

    Lack of knowledge of person who is performing risk assessment.

    As flow chart is primary required to identify various secondary and tertiary component followed by asking question depends on why, excees ,less, without, no interlock, no identification, absent, without etc.

    We are not segregating the design, equipment, process, and system fmea,

    Anonymous while doing RPN.

    Lots more .

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    Stephen Clarke

    Looking forward to the session Yan.

    For the other attendees it may be worth looking into the recent ITH Pharma legal case in the UK as an example of what can happen when risks are assessed badly.

    Stephen

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