Outsourcing Surveillance Activities
In this episode, host Erika Porcelli is joined by Steve Cox, a Senior Consultant at Regulatory Compliance...
Archives: Courses
Navigating upcoming changes in Chemical Characterization according to revised ISO 10993-18
The final draft revision of part 18 of the ISO 10993 series, now titled “Chemical Characterization of...
Biocompatibility and the New MDR
This presentation will provide an in-depth overview of biocompatibility in compliance with the new Medical Device Regulations...
Navigating Packaging Changes in Light of New Regulatory Requirements
With the deadline for implementing the new Medical Device Regulation (MDR) fast approaching, it is crucial for...
Data Integrity and Quality Culture
In this episode, host Erika Porcelli is joined by Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates...
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...
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...
Transportation and Distribution Testing for Medical Devices
An essential yet sometimes overlooked component of packaging shelf life validation is transportation and distribution testing. This...
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...
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...
What is a Sterilization Dose Audit and How are they Performed?
The performance of periodic sterilization dose audits is required when a sterilization dose has been established using...
Becoming Compliant with the MDRs, A Real Life Case Study
The new Medical Device Regulations (MDRs) became enforceable in May 2022. This significant regulatory shift requires that...
3D Printed Medical Devices and Biocompatibility Whitepaper
The use of three-dimensional (3D) printing techniques to address challenging fabrication problems has become mainstream over the...
Choosing Colorants for Medical Devices
Colorants are frequently added to the substrates and material components of medical devices to enhance usability and...
Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices
3D-printed orthopedic medical devices have gained significant attention due to their potential for enhanced biocompatibility, customizability, and...