Validating, Optimizing and Monitoring EO Sterilization Processes – Part 1
Establishing an EO (ethylene oxide) sterilization process can be a complicated path as multiple factors play a...
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Effective Auditing for Manufacturing Quality
Gain confidence that your product meets the necessary quality standards and ensure compliance with the guidance of...
Future Trends To Control Risks From Extractables and Leachables
Prior to 2018, ophthalmic drug products (ODPs) and parenteral drug products (PDPs) underwent similar processes for Extractables...
The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
A Delay in MDR? Where are we now?
With the onset of the COVID-19 crisis, the implementation of the Medical Device Regulations (MDR) has been...
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...
An Outline of Current Medical Face Mask Performance Requirements and Testing
The current pandemic has brought medical face masks and respirators into the spotlight, highlighting the critical need...
Cleaning Validations for Reusable Devices A Road Trip to the EU and US Market
Reprocessing validations for reusable medical devices have often been neglected, but recent regulatory developments have brought their...
Recent FDA biocompatibility feedback from 510k submissions
Navigating the FDA approval process for a medical device can be a daunting and stressful experience for...
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
Lyophilized drug products, also known as freeze-dried pharmaceuticals, require specialized containers and administration devices to ensure their...