Aging Facilities and In-Shoring Product to the US
In this episode, host Erika Porcelli is joined by Brendan McCrea, Regulatory Compliance Associates (RCA) Director of...
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Expedited Approvals and the Regulatory Impacts and FDA’s Long Term Strategy
With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are...
Supply Chain Management Audit Effectiveness and Oversight
With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are...
Internal Audit Be Ready for FDA Inspections Hope is not a Strategy
Life science companies recognize that the FDA inspection process is a cornerstone of ensuring the safety and...
Pharma Product Launch and Lessons Leaned Crisis Playbook: Lessons learned from Real Investigations of Product Failures
When a medical or pharmaceutical product fails in the field, the repercussions are far-reaching. Not only do...
