The RAPS Florida Chapter and Pilgrim Quality Solutions invite you to participate in a 60-minute webcast covering the importance of quality metrics in regulatory, with particular focus on the differences between CDER and CDRH initiatives.
In 2011, CDRH launched “The Case for Quality” initiative in an effort to advance the focus of industry and FDA beyond compliance towards higher assurance of quality. In 2012, the FDA Safety and Innovation Act (FDASIA) was passed by Congress. Since that time, industry has seen CDRH and CDER move in different directions and at a different pace towards end goals that seem similar, but yet unclear.
Our featured presenter, Marla A. Phillips, Ph.D., co-led with FDA the CDRH Metrics Initiative and co-led with PricewaterhouseCoopers the pharmaceutical metrics initiative, and will address the following points:
Why there are differences between the CDER and CDRH metrics initiatives
The progress of both initiatives
The device and pharma metrics—differences and similarities
This webinar will include additional insights from Kari Miller, Pilgrim Quality Solutions’ Vice President of Regulatory & Product Management. She’ll address the ways in which these FDA initiatives affect quality management systems, how to structure quality data, and how to effectively report against it.
We hope you are able to join us for this timely industry presentation on April 27th.