New FDA Draft Guidance for Chemical Analysis
In this podcast our host Brandon Miller from Regulatory Compliance Associates is joined by Raymond Colton, Director of E&L...
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ISO 10993-1: Key update on the new revision of this critical standard
This webinar delves into the latest updates to ISO 10993-1, the cornerstone standard guiding biocompatibility assessment for...
Reprocessing Rethought: An Open Forum Discussion On Approaches for Cleaning Validations of Single-Use 3D Printed Devices Processed at Healthcare Facilities
The presence of 3D printed single-use devices that require processing (cleaning and disinfection or sterilization) at the...
Documenting Device Changes in Biological Risk Assessments: Part Three
This is the third whitepaper in a four-part series covering different examples of how to document device...
Documenting Device Changes in Biological Risk Assessments: Part Two
This whitepaper, the second in a four-part series covering different examples of device changes to be documented...
Transitioning From Cell-Based Assays to qPCR-Driven Analyses To Ensure Viral Safety in Biologics Manufacturing
The production of biological products in biopharmaceutical manufacturing involves significant risks of viral contamination from human and...
Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety....
Disinfectant Efficacy Testing on Site-Specific Surfaces
This whitepaper focuses on the importance of disinfectant validations based on real-world conditions to maintain cGMP compliance...
Documenting Device Changes in Biological Risk Assessments: Part One
“Device changes can range in complexity, making it critical that each change be treated uniquely and assessed...
Reprocessing Rethought: An Open Forum Discussion On Novel Decontamination Methods for Reusable Medical Devices
As reusable medical devices have advanced, the importance of effective decontamination methods (cleaning, disinfection, and/or sterilization) has...