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...
Archives: Courses
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...
History & Modern Practices for ASTM E1174: Evaluating the Effectiveness of Healthcare Personnel Handwash Formulations
ASTM E1174 was first developed in 1987 and was developed to evaluate Healthcare Personnel Handwash (HCPHW) Formulations...
Focus on Fundamentals: Day 3 – Toxicological Considerations of VH2O2 Sterilization Residuals
VH2O2 sterilization may leave hydrogen peroxide residuals on the device materials after the sterilization process whose toxicological...
Focus on Fundamentals: Day 2 – Considerations for Biocompatibility
Biocompatibility assessments involve extensive evaluation, and changing the sterilization modality, such as to VH2O2, can trigger considerable,...
Focus on Fundamentals: Day 1 – VH2O2, Sterilization Considerations
VH2O2 has been a common sterilization option for reusable devices for many years. Interest has increased for...
Introduction to Sotera Health
Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services...
How QMS Impacts Quality Maturity
In this webinar Susan Schniepp from Regulatory Compliance Associates explores various strategies behind quality maturity. Learn about regulation changes...
Handling Unexpected Biocompatibility Test Results in Medical Device Development
Getting unexpected or failing test results for any biocompatibility test can feel like the end of the...
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....
Biocompatibility Testing: What You Need to Know
When it comes to biocompatibility testing on medical devices, there are many aspects that have to be...
Advancing Microbial-Contamination Detection Through Rapid Sterility Testing
Increasing industry and product demand for expedited product release reinforces the need to embrace rapid sterility technologies....
What’s New with Reprocessing Validations for Reusable Medical Devices?
There have been many great strides surrounding the guidance for reprocessing (cleaning, disinfection, and/or sterilization) validations for...
Disinfectant Efficacy Testing on Site Specific Surfaces
Disinfection efficacy studies play a significant role in the Pharmaceutical manufacturing environment in ensuring that the surfaces...
How to design an Instruction For Use and validations for EU and US
In this free on-demand webinar, Kathleen Peymen, PhD, Senior Expert, takes you on an road trip to discover...
Navigating the FDA’s Medical Device Pre-submission Process
This presentation provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for...
Biocompatibility as a Critical Design Input
For any medical device contacting a patient, a biocompatibility evaluation is required before the device can be...
Disinfectant Efficacy Testing on Site Specific Surfaces
Disinfection efficacy studies play a significant role in the Pharmaceutical manufacturing environment in ensuring that the surfaces...
What’s New with Reprocessing Validations for Reusable Medical Devices?
There have been many great strides surrounding the guidance for reprocessing (cleaning, disinfection, and/or sterilization) validations for...
Advancing Microbial-Contamination Detection Through Rapid Sterility Testing
Increasing industry and product demand for expedited product release reinforces the need to embrace rapid sterility technologies....