Recent FDA biocompatibility feedback from 510k submissions
Navigating the FDA approval process for a medical device can be a daunting and stressful experience for...
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Why is the Sterility of your Drug Product much more than just a Test of Sterility?
Ensuring sterility and sterility assurance is crucial in the pharmaceutical industry, as the lack of these can...
Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems
Over the past few decades, the scrutiny applied by EMEA and FDA regulators to extractables and leachables...
Key Elements of a Sterility Assurance Program
This webinar will delve into various aspects of a sterility assurance program for pharmaceutical products, emphasizing its...
Shifting Requirements Within the FDA: Expectations in Chemistry Study Design
The FDA’s expectations regarding the design of chemistry studies in support of medical device toxicology have been...
Discussion of Feedback Received Directly from FDA on ChemTox
In this webinar, we will share the latest trends in feedback received from the FDA concerning extractables...
Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces
Qualifying disinfectants on surfaces within a pharmacopeial manufacturing environment is a crucial step before they can be...
Chemical Characterization on a Combination Device for Biological Evaluation Plan to Practice
Join Dr. Annelies Vertommen and Dr. Sophie Michel in this insightful webinar as they delve into the...
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...
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...
