Recent FDA biocompatibility feedback from 510k submissions
Navigating the FDA approval process for a medical device can be a daunting and stressful experience for...
Archives: Courses
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...
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...
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...
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...
Supply Chain Risk Management
With manufacturers in the United States and around the world facing significant supply chain challenges, understanding how...
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...
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...
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...
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...
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...
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...