Assessing the Safety of Extractables and Leachables for Drug Products: When and How?
In this insightful webinar, Kevin Breesch of Nelson Labs will address the significant challenges associated with toxicological-safety...
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EO Sterilization: Considerations for Neonate Products and Medical Devices & ISO 10993-7
Ethylene oxide (EO) sterilized items are life-saving and critical devices that undergo sterilization in highly regulated environments,...
Laboratory Out of Specification Investigations
In this episode, host Brandon Miller is joined by Walter Mason, Senior Director of Quality Control and...
Case Study Quality Complaint Investigations
In this episode, host Brandon Miller is joined by Walter Mason, Senior Director of Quality Control and...
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...
