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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Extractables and leachables testing of a combination device: testing in between regulations for pharmaceutical products and medical devices
Extractables and leachables (E&L) testing of combination devices requires a specific study setup that differentiates from a...
Case Study: Warning Letter Remediation
In this episode, host Brandon Miller is joined by Steven Lynn, Executive VP of Pharmaceuticals at Regulatory...
Understanding the Power of the FDA Pre-Sub: Tips for a Successful Meeting
The submission process to the FDA can be a stressful and uncertain time for a medical device...
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)...
The Design and Qualification Process for a LVP Packaging System from a User Perspective
To meet the growing patient need for Large Volume Parenterals (LVP), increasingly complex packaging systems must be...
Design of Protocols for Biologics
In this episode, host Brandon Miller is joined by Steve Lynn, Executive VP of Pharmaceuticals, and Walter...
Bioburden Alert and Action Levels – Low Hanging Fruit for a FDA Citation
Most standards regarding bioburden and environmental testing emphasize the importance of establishing alert and action levels. These...
Design Change Impact on Biocompatibility and Documentation
Change management in the design of medical devices is a critical process, frequently highlighted in FDA 483...
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...