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  • A Framework For Measuring Training ROI Using Quality Metrics
    A Framework For Measuring Training ROI Using Quality Metrics

    This article proposes an approach using data-driven insights from standard quality culture and performance metrics, with CoPQ calculations, to measure training return on investment (ROI). Calculation of ROI answers the question, “Is this investment worth the expense?” It measures how much money is earned or lost from investment in training and the impact of training on the bottom line.

  • An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection
    An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection

    This article discusses how the maximum safe surface residue (MSSR) can be combined with the visual residue limit (VRL) to assess the acceptability of visual inspection for detecting the possibility of compound carryover in shared facilities.

  • The FDA/EU Mutual Recognition Agreement — What You Need To Know
    The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

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A Framework For Measuring Training ROI Using Quality Metrics A Framework For Measuring Training ROI Using Quality Metrics

This article proposes an approach using data-driven insights from standard quality culture and performance metrics, with CoPQ calculations, to measure training return on investment (ROI). Calculation of ROI answers the question, “Is this investment worth the expense?” It measures how much money is earned or lost from investment in training and the impact of training on the bottom line.

An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection

This article discusses how the maximum safe surface residue (MSSR) can be combined with the visual residue limit (VRL) to assess the acceptability of visual inspection for detecting the possibility of compound carryover in shared facilities.

The FDA/EU Mutual Recognition Agreement — What You Need To Know The FDA/EU Mutual Recognition Agreement — What You Need To Know

The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

Best Practices For Data Integrity Oversight At Your Contract Manufacturer Best Practices For Data Integrity Oversight At Your Contract Manufacturer

Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.

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TITLE SUMMARY DISPLAY

  • A Framework For Measuring Training ROI Using Quality Metrics

    This article proposes an approach using data-driven insights from standard quality culture and performance metrics, with CoPQ calculations, to measure training return on investment (ROI). Calculation of ROI answers the question, “Is this investment worth the expense?” It measures how much money is earned or lost from investment in training and the impact of training on the bottom line.

  • An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection

    This article discusses how the maximum safe surface residue (MSSR) can be combined with the visual residue limit (VRL) to assess the acceptability of visual inspection for detecting the possibility of compound carryover in shared facilities.

  • The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

More From Pharma Contributing Editors

GRID WITH IMAGE DISPLAY

A Framework For Measuring Training ROI Using Quality Metrics A Framework For Measuring Training ROI Using Quality Metrics

This article proposes an approach using data-driven insights from standard quality culture and performance metrics, with CoPQ calculations, to measure training return on investment (ROI). Calculation of ROI answers the question, “Is this investment worth the expense?” It measures how much money is earned or lost from investment in training and the impact of training on the bottom line.

An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection

This article discusses how the maximum safe surface residue (MSSR) can be combined with the visual residue limit (VRL) to assess the acceptability of visual inspection for detecting the possibility of compound carryover in shared facilities.

The FDA/EU Mutual Recognition Agreement — What You Need To Know The FDA/EU Mutual Recognition Agreement — What You Need To Know

The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

More From Pharma Contributing Editors