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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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...
Microbiological Control in a Pharmaceutical Manufacturing Environment
This webinar will focus on the evaluation of microbiological and environmental monitoring data, highlighting what constitutes significant...
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...
Navigating upcoming changes in Chemical Characterization according to revised ISO 10993-18
The final draft revision of part 18 of the ISO 10993 series, now titled “Chemical Characterization of...
Biocompatibility and the New MDR
This presentation will provide an in-depth overview of biocompatibility in compliance with the new Medical Device Regulations...
Navigating Packaging Changes in Light of New Regulatory Requirements
With the deadline for implementing the new Medical Device Regulation (MDR) fast approaching, it is crucial for...
Packaging Validations – A look at Current and Future State Testing
This Nelson Labs webinar will delve into the significant changes brought about by the release of the...
Designing an End-to-End Sterility Assurance Program
Sterility assurance for pharmaceutical products is of paramount importance, encompassing numerous aspects beyond the actual sterilization cycle...
