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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The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
Lyophilized drug products, also known as freeze-dried pharmaceuticals, require specialized containers and administration devices to ensure their...
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...
Virtual Audits and Inspections
Companies across the globe have had to pivot significantly due to the pandemic, transitioning many key face-to-face...
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...
Aging Facilities and In-Shoring Product to the US
In this episode, host Erika Porcelli is joined by Brendan McCrea, Regulatory Compliance Associates (RCA) Director of...
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...
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...
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...