Packaging Validations – A look at Current and Future State Testing
This Nelson Labs webinar will delve into the significant changes brought about by the release of the...
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Designing an End-to-End Sterility Assurance Program
Sterility assurance for pharmaceutical products is of paramount importance, encompassing numerous aspects beyond the actual sterilization cycle...
MDR Effects on Cleaning and Sterilization Validations
The new Medical Devices Regulation (2017/745/EU) (MDR) aligns EU legislation with the latest technical advances, changes in...
Establishing Maximum Acceptable Dose in Radiation Sterilization
Manufacturers utilizing ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the maximum acceptable...
Chemical Interactions between Leachables and Biopharmaceuticals
In the evaluation of pharmaceutical drug products, leachable compounds are typically assessed primarily for the toxicological risks...
Artificial Intelligence and Machine Learning Based Software as a Medical Device
In our first episode, host Erika Porcelli is joined by Lisa Michels, General Counsel and Regulatory Affairs...
Mass Extraction Container Closure “CCIT” for Rigid Containers
Mass extraction is a relatively new method for container closure integrity testing (CCIT) that has been included...
Transportation and Distribution Testing for Medical Devices
An essential yet sometimes overlooked component of packaging shelf life validation is transportation and distribution testing. This...
Biocompatibility: Applying the New ISO 10993 Standards
Biocompatibility is a critical aspect of medical device development, ensuring that devices are safe and do not...
Critical First Steps of an Ethylene Oxide (EO) Validation – Process Definition Process Definition The Critical First Steps in the Validation of an EO Sterilization Process
In this webinar, you will learn about the importance of process definition (fractional) work as a part...