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The U.S. Food and Drug Administration (FDA) conducts on-site investigations for organizations that manufacture and package drugs to protect patient safety and maintain a high-quality standard in the life science...

Do you understand how risk management strategy impacts design controls? Join Dr. Stephen Coulter as he presents an in-depth overview of the Waterfall design model and addresses the question, Are...

Since the 1950’s the irradiation of medical devices using electron beam (e-beam) sterilization has been a common practice. Decades later, as medical devices and packaging configurations have become more complex,...

The transmission of infections via endoscopy remains a critical concern due to the inherent design challenges of scopes. Single-Use endoscopes offer a pivotal solution by eliminating the risk of patient-to-patient...

Learn more about contamination control strategies (CCS), how to identify and assess risks, prepare mitigation pathways, and define preventative actions associated with contamination in sterile product manufacturing.

Click to watch our webinar with Susan Schniepp as she explores how quality maturity strategies can impact the continuous improvement process. You’ll learn about regulation changes and how each can...