Key Elements of a Sterility Assurance Program
This webinar will delve into various aspects of a sterility assurance program for pharmaceutical products, emphasizing its...
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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...
Pharma Packaging Considerations for Radiation Processing using Gamma and Electron Beam and Discussion on the New Container Closure Integrity Testing
This webinar is designed to enhance your foundational knowledge of pharmaceutical packaging, particularly focusing on its critical...
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...
Outsourcing Surveillance Activities
In this episode, host Erika Porcelli is joined by Steve Cox, a Senior Consultant at Regulatory Compliance...
Data Integrity and Quality Culture
In this episode, host Erika Porcelli is joined by Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates...
Navigating Complexities of Name Changes and Re Registrations
Medical device manufacturers often overlook the complexities involved in changing product names or ownership, both of which...
Merger and Acquisition Re Registration: Navigating the Re Registration and other Complexities of M and A and Carve Outs
In M&A or carve-outs, pharmaceutical executives often underestimate the complexities of disentangling operations and the extensive effort...
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...