Case Study Quality Complaint Investigations
In this episode, host Brandon Miller is joined by Walter Mason, Senior Director of Quality Control and...
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Case Study: Warning Letter Remediation
In this episode, host Brandon Miller is joined by Steven Lynn, Executive VP of Pharmaceuticals at Regulatory...
What Makes a Great Quality Management System
In this episode, guest host Dean Coston is joined by Susan Schniepp, Regulatory Compliance Associates Inc.’s (RCA)...
Design of Protocols for Biologics
In this episode, host Brandon Miller is joined by Steve Lynn, Executive VP of Pharmaceuticals, and Walter...
On Site Inspections: They’re Back – But When, Where and How
With the development and distribution of COVID-19 vaccines, the global health crisis is beginning to ease in...
Best Practices for Investigating Quality Deviations
The COVID-19 pandemic has led to a significant backlog of delayed inspections, and the FDA is now...
Preparing for FDA Remote Inspections
Stay ahead of the curve by learning from experts about virtual inspection training, preparing you for next...
Effective Auditing for Manufacturing Quality
Gain confidence that your product meets the necessary quality standards and ensure compliance with the guidance of...
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...
Virtual Audits and Inspections
Companies across the globe have had to pivot significantly due to the pandemic, transitioning many key face-to-face...