Rapid Sterility Testing: Enhancing Compliance, Efficiency, and Accuracy
This webinar examines how rapid sterility testing technologies enhance efficiency, reduce time-to-results, and improve overall product safety...
Archives: Courses
Benefits of Parametric Release for EO Sterilization
Introducing Capsule Learning from Sterigenics. All the expertise of a webinar in 30 minutes or less. Join...
Gamma: Sustainable Sterilization for the Long Term
Gamma sterilization has been the predominant radiation sterilization modality for decades and accounts for more than 30%...
Sustaining the Continued Safe Use of EO: Cycle Design and Optimization
Join us for an insightful webinar on Sterigenics’ ongoing efforts and commitment to sustaining the continued safe...
Nitrogen Dioxide: Innovative Gas Solutions for Healthcare Products
Finding the appropriate sterilization modality for your product requires an understanding of the options. Nitrogen Dioxide is...
Prefilled Ophthalmic Syringes New Possibilities in Terminal Sterilization
In this joint webinar, Eric Offermann and Bernd Zeiss speak about Nitrogen Dioxide (NO2) as a new...
New FDA Draft Guidance for Chemical Analysis
In this podcast our host Brandon Miller from Regulatory Compliance Associates is joined by Raymond Colton, Director of E&L...
ISO 10993-1: Key update on the new revision of this critical standard
This webinar delves into the latest updates to ISO 10993-1, the cornerstone standard guiding biocompatibility assessment for...
Reprocessing Rethought: An Open Forum Discussion On Approaches for Cleaning Validations of Single-Use 3D Printed Devices Processed at Healthcare Facilities
The presence of 3D printed single-use devices that require processing (cleaning and disinfection or sterilization) at the...
Documenting Device Changes in Biological Risk Assessments: Part Three
This is the third whitepaper in a four-part series covering different examples of how to document device...
Documenting Device Changes in Biological Risk Assessments: Part Two
This whitepaper, the second in a four-part series covering different examples of device changes to be documented...
Transitioning From Cell-Based Assays to qPCR-Driven Analyses To Ensure Viral Safety in Biologics Manufacturing
The production of biological products in biopharmaceutical manufacturing involves significant risks of viral contamination from human and...
Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety....
Disinfectant Efficacy Testing on Site-Specific Surfaces
This whitepaper focuses on the importance of disinfectant validations based on real-world conditions to maintain cGMP compliance...
Documenting Device Changes in Biological Risk Assessments: Part One
“Device changes can range in complexity, making it critical that each change be treated uniquely and assessed...
Reprocessing Rethought: An Open Forum Discussion On Novel Decontamination Methods for Reusable Medical Devices
As reusable medical devices have advanced, the importance of effective decontamination methods (cleaning, disinfection, and/or sterilization) has...
Regulatory Insights: The Future of MedTech and Pharma Under the New Administration
The new presidential administration in the United States could significantly impact MedTech and pharmaceutical regulations for manufacturers...
Navigating the FDA’s Medical Device Presubmission Process
This webinar provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for...
Updates to ISO-18562:2024 – A CRO Point of View
The 2024 updates to the ISO 18562 series of standards bring quite a few changes. In this...
