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Modernizing Management Review: Meeting New FDA QMSR Expectations

Air Date: Wednesday, February 11th

The FDA Quality Management System Regulation (QMSR) has redefined Management Review as inspectable evidence of executive oversight. What was once a reporting exercise is now a direct reflection of how leadership monitors risk, performance, and control.
 
In this webinar, we will show how FDA-regulated companies are modernizing Management Review using an evidence-based Executive Scorecard aligned to QMSR expectations.
Attendees will learn how to structure KPIs, governance, escalation logic, and automation to reduce inspection risk while strengthening executive decision-making.
 

Key takeaways include:

QMSR Shift: Management Review is now inspectable evidence of executive oversight, reflecting leadership’s role in monitoring risk, performance, and control.
QMSR Shift: Management Review is now inspectable evidence of executive oversight, reflecting leadership’s role in monitoring risk, performance, and control.
Modernization Approach: Companies are adopting evidence-based Executive Scorecards aligned with QMSR expectations.
Modernization Approach: Companies are adopting evidence-based Executive Scorecards aligned with QMSR expectations.
Practical Takeaways: Attendees will learn to structure KPIs, governance, escalation logic, and automation to reduce inspection risk and strengthen decision-making.
Practical Takeaways: Attendees will learn to structure KPIs, governance, escalation logic, and automation to reduce inspection risk and strengthen decision-making.

Register to watch the full recording

Speaker

Mark Morgan Mark Morgan
Mark Morgan
Partner, Life Sciences Solutions GoSaaS, Inc.

With over 30 years of global experience, Mark has led supply chain and PLM initiatives across major corporations in the U.S. and internationally.
He spent 10 years at LifeScan, a Johnson & Johnson company, where he led the Instruments Supply Chain Planning group and drove strategic improvements in Quality Excellence, Lean Manufacturing, and employee training.
Mark then joined Palm, where he led the Supply Chain Planning & Systems group and guided a global SAP implementation during a year in the IT organization.
He went on to spend 11 years at Agile and Oracle, leading PLM consulting practices and engagement teams. His focus was on business process design and solution architecture for Agile PLM.
In 2012, Mark founded Mazamo, a strategic consulting firm focused on enabling successful innovation processes from ideation to commercialization. Notable projects include implementations at Agilent and Alere (now part of Abbott).
Mark holds an MBA in Finance from Santa Clara University and a BS in International Business from San Jose State University.