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...
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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...
Regulatory Insights: The Future of MedTech and Pharma Under the New Administration
The new presidential administration in the United States could significantly impact MedTech and pharmaceutical regulations for manufacturers...
Navigating the FDA’s Medical Device Presubmission Process
This webinar provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for...
Updates to ISO-18562:2024 – A CRO Point of View
The 2024 updates to the ISO 18562 series of standards bring quite a few changes. In this...
Unmasking the Unknown: How Mass Spectrometry Delivers Accurate Identifications
In this webinar, presented by our Senior Expert LC/MS, Ruud Cuyvers, you’ll expand your knowledge on unexpected impurities in Drug...