Overview:
The quality management review is fundamental to ensuring that the quality management system is operating properly, and that manufacturing and distribution processes undergo continuous improvement. QMR presentations, meeting minutes and other documentation is on every inspector's checklist.
Why you should Attend:
Conducting an effective management review is a central part of any quality management system. Management review records and presentations are on any inspector’s checklist. Effective management reviews support operational excellence. Ineffective management reviews can trigger warning letters and additional sanctions.
This webinar will provide insights into health authority expectations relating to management reviews, as well as layout standard categories and metrics to support management reviews. The session will layout and distinguish among metrics categories including KPIs, Management review metrics, and operational metrics.Â
The session will also discuss best practices and lessons learned for QMR preparation and post review follow up including CAPA initiation and continuous improvement projects.
Areas Covered in the Session:
Who Will Benefit:
Patterson Shafer has over 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of quality and compliance, regulatory affairs and operations, clinical, safety and surveillance, manufacturing, supply chain, medical affairs and commercial.
Pat has extensive knowledge and experience with post-market surveillance and field actions, including recall readiness. His work in that area includes identifying technology solutions to detect quality and safety signals, reengineered pharmacovigilance, complaint, CAPA and field action (recall) processes, and redesigned medical review organizations to advance compliance, safety, and operational efficiency. He has written recall best practices playbooks, published articles, and presented at multiple conferences on the subject, in addition to overseeing multiple recalls for medical device companies.