Data Integrity and Quality Culture During the Pandemic
In this episode, host Brandon Miller is joined by Steven Lynn, Executive Vice President of Pharmaceuticals at...
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Virtual Audits and Inspections
Companies across the globe have had to pivot significantly due to the pandemic, transitioning many key face-to-face...
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...
Supply Chain Risk Management
With manufacturers in the United States and around the world facing significant supply chain challenges, understanding how...
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...
US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
Outsource Quality and Regulatory Agencies: Right-Sizing Need and Cost
Small or emerging life science organizations often face the dilemma of when to hire Quality and Regulatory...
Animal Testing
Traditionally, animals have been used as test subjects during drug development studies to reliably detect the toxic...
Challenges in Design Development – Why Design Control Makes Sense
The journey from a novel idea for a new medical product to its commercial realization involves significant...