Endotoxin Retention Testing for Filters
Bacterial endotoxins can negatively impact the quality and effectiveness of pharmaceutical products, medical devices, and other materials,...
Archives: Courses
Always Inspection Ready: Mastering FDA Inspection Preparation and Response
With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This...
Understanding PDA/ANSI Standard 06-2025: A Roadmap for Culture Change
A robust quality culture is no longer a nice to have—it’s a regulatory and operational imperative. Watch...
Expanding Your Pharmaceutical QMS for Combination Product Success
As combination products, such as prefilled syringes, auto-injectors, and drug-device kits, become more prevalent, pharmaceutical and biologic...
Ensuring Drug–Device Compatibility: Foundations for Safe and Effective Combination Products
As combination products continue to advance healthcare, ensuring compatibility between drug formulations and device components is essential...
Reprocessing Rethought: Mastering the Worst-Case Soil Challenge
To perform cleaning validations according to ANSI/AAMI ST98:2022, the intended use and clinical conditions of medical devices...
Nordion Technology to Help Control Spread of New World Screwworm in Mexico
The New World screwworm is a species of parasitic fly that eats live tissue. After being eradicated...
2-part webinar: Navigating the 2025 ISO 10993-1 Revision + Challenges Encountered During ISO 10993-18 Testing & Possible Ways Out
Part 1 Navigating the 2025 ISO 10993-1 Revision ISO 10993‑1 is the standard that outlines the framework for the...
Data Integrity in the Age of AI: Securing Connected Devices
As artificial intelligence becomes increasingly embedded in medical devices and healthcare systems, the concept of data integrity...
Human Factors Engineering for Medical Devices From Concept Through Reprocessing and Post-market Surveillance
Human factors engineering (HFE), also referred to as usability engineering, is a structured, risk-based process intended to...
Reprocessing Implants: Challenges for Validation
Implant caddies or similar implant storage units for single use implants are commonly opened and exposed during...
Optimizing Ethylene Oxide Sterilization: Sustainable Solutions for Pharmaceutical Packaging and Drug Delivery Devices
Ethylene oxide (EO) remains the sterilization method of choice for approximately 50% of all single-use medical devices...
Calculation of the Duration of Exposure and Associated Biological Effects for Biocompatibility Evaluation
In the biocompatibility assessment of medical devices, two of the primary points of consideration are how long...
End-to-End Human Factors for Medical Devices and Reprocessing Usability Testing
Human factors engineering is essential to designing medical devices and healthcare products that are safe, intuitive, and...
Fundamentals of Disinfectant Efficacy
Disinfectants must be qualified on the surfaces present within a pharmaceutical manufacturing environment before they are approved...
Accelerating Product Release Through Patent-Pending RapidCert™ Biological Indicator (BI) Sterility Testing
RapidCert™ BI testing offers a transformative approach to biological indicator testing, delivering faster results than traditional compendial methods—incubation...
Reprocessing Considerations during Design Development for Reusable Medical Devices
Reusable medical devices are medical devices intended for repeated use on patients. These devices range from simple,...
Sterilization by Filtration: Validating Filtration for an Aseptic Process
This presentation explores the validation of sterilization by filtration as a critical step in aseptic pharmaceutical processing....
Applications Of Mathematical Modelling at Gamma Irradiator Sites
This will present two case studies of applications at customer sites to help the sites improve efficiency...
Growing Cobalt-60 Supply for a Sustainable Future
This review of the global Cobalt-60 supply chain is critical in understanding the current state and future...