The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
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Establishing Bioburden Alert and Action Levels
In the realm of bioburden, sterilization, and environmental testing, national and international standards play a crucial role...
Meeting the Requirements of 10.4 of MDR How to Address CMRs
Ensuring compliance with the Medical Device Regulation (MDR) requires a thorough evaluation of medical devices for the...
Animal Testing
Traditionally, animals have been used as test subjects during drug development studies to reliably detect the toxic...
Challenges in Design Development – Why Design Control Makes Sense
The journey from a novel idea for a new medical product to its commercial realization involves significant...
US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
Microbiological Control in a Pharmaceutical Manufacturing Environment
This webinar will focus on the evaluation of microbiological and environmental monitoring data, highlighting what constitutes significant...
Considerations for Third Party Reprocessing of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by third-party reprocessors can enable healthcare providers to maintain...
MPO Packaging Validations – A Look at Current and Future State Testing
This webinar will explore the significant changes implemented with the release of the Medical Device Regulation (MDR)...
Guidance for Cleaning, Disinfection and Sterilization of Reusable Medical Devices
All reusable medical devices must include specific instructions for cleaning, disinfecting, and/or sterilization to ensure patient safety...