Design of Protocols for Biologics
In this episode, host Brandon Miller is joined by Steve Lynn, Executive VP of Pharmaceuticals, and Walter...
Archives: Courses
Bioburden Alert and Action Levels – Low Hanging Fruit for a FDA Citation
Most standards regarding bioburden and environmental testing emphasize the importance of establishing alert and action levels. These...
Design Change Impact on Biocompatibility and Documentation
Change management in the design of medical devices is a critical process, frequently highlighted in FDA 483...
On Site Inspections: They’re Back – But When, Where and How
With the development and distribution of COVID-19 vaccines, the global health crisis is beginning to ease in...
Cleaning, Disinfection and Sterilization of Medical Devices: Updates to Reprocessing Guidance Documents AAMI TIR 12 and TIR30 (ST98)
The cleaning, disinfection, and sterilization of medical devices are critical processes that ensure patient safety and device...
After E&L Updates to the Standard for Toxicological Risk Assessment 10993-17
The use of extractables and leachables (E&L) chemistry testing has become integral and often essential in the...
Cytotoxic Reactivity Understanding the Cause and the Path Forward
All medical devices intended to contact patients must undergo a rigorous biological evaluation to ensure their safety....
Best Practices for Investigating Quality Deviations
The COVID-19 pandemic has led to a significant backlog of delayed inspections, and the FDA is now...
LVP Polyolefin Solutions Addressing Different Packaging and Regulatory Requirements
Large Volume Parenterals (LVPs) can be packaged in a variety of formats made from polyolefins, including pouches,...
Preparing for FDA Remote Inspections
Stay ahead of the curve by learning from experts about virtual inspection training, preparing you for next...
Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18
All medical devices that are intended to contact patients or medical personnel (directly or indirectly) require an...
Primary and Secondary Packaging Materials as Potential Source of Nitrosamines
Recently, several drug product recalls have occurred due to the unexpected presence of N-Nitrosamines. While the formation...
Risk Assessment for Potential Elemental Impurities on Drug Products and Medical Devices
When submitting drug products for approval, regulatory authorities frequently ask, “Are you submitting your risk assessment for...
The Big Three: Cytotoxicity, Sensitization & Irritation Testing
Among the myriad of tests that medical device manufacturers must conduct, none are more critical than the...
Successfully Execute a Nitrogen Dioxide Sterilization Validation for a Drug in a Pre-Filled Syringe
Biotech drugs are currently the fastest growing segment within pharmaceutical and biotech pipelines, with approximately 60-70% of...
Packaging Validation 101
Have you ever wondered how to set up a packaging validation according to ISO 11607? Join us...
Hunt for N-nitrosamines in Medicinal Products
In the EMA newsletter published in September 2019, the pharmaceutical industry received a significant wake-up call regarding...
The Testing and Risk Management Impacts of Changing a Medical Device
Throughout its product life cycle, a medical device and its support system can undergo numerous changes—sometimes even...
PQ dose mapping and routine irradiation of products with non-uniform density distribution
Operational Qualification (OQ) dose mapping of gamma irradiators typically involves using homogeneous materials. However, the real-world scenario...
Best Practices When Validating Reusable Devices
The advancement of reusable medical devices has significantly transformed the medical device industry, bringing about changes in...