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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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...
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...
Developing a Quality System on a Budget
Developing a robust quality system is fundamental to ensuring that an organization’s products or services are safe,...
GMPs for Early Stage Development Projects
Good Manufacturing Practices (GMPs) should be implemented during the later stages of clinical development, where the final...
Implementing Risk Managed Supplier Quality
A risk-managed approach to the global supply chain is more important than ever for life science manufacturers....