Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE)
Throughout the COVID-19 crisis, there has been a significant emphasis on rapidly bringing critical products to the...
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FDA Feedback Reguarding Chemistry for Toxicological Risk Assessment – How to Make Sure FDA will Accept Your Protocol
Understanding the latest trends in FDA feedback regarding extractables chemistry testing is crucial for ensuring compliance and...
COVID-19, what we learned from the race to supply the market with respirators, masks, and other PPE
During these unprecedented times, medical device companies have had to be exceptionally agile and responsive. During the...
Reprocessing Validations of Reusable Medical Devices
Reprocessing validations of reusable medical devices have often been neglected, with their importance underestimated until recently. However,...
Identifying and Mitigating Errors in Organic Extractables and Leachables Screening
The practice of Organic Chromatographic Screening, aimed at discovering, identifying, and (semi-)quantifying organic compounds in extracts from...
Expedited Approvals and the Regulatory Impacts and FDA’s Long Term Strategy
With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are...
Materials Qualification of Healthcare Products to Radiation Sterilization
Newer medical products, particularly those that are biological in nature or composed of materials sensitive to traditional...
Pharma Packaging Considerations for Radiation Processing using Gamma and Electron Beam and Discussion on the New Container Closure Integrity Testing
This webinar is designed to enhance your foundational knowledge of pharmaceutical packaging, particularly focusing on its critical...
When drug meets device: How to assess compatibility?
The frequent use of combined products, which involve the joint application of drugs and medical devices, underscores...
Supply Chain Management Audit Effectiveness and Oversight
With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are...