Risk Assessment for Single Use Systems: USP 665 vs. BPOG
Disposable plastic components are increasingly popular in biopharmaceutical drug manufacturing systems due to their cost-effectiveness and reduced...
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Product Adoption for Ethylene Oxide Sterilization
Changes to the design of an existing product or the adoption of a new product into a...
ProDisinfectant Efficacy Testing Coupon/Carrier Method
Disinfectants must be qualified on the surfaces within a pharmacopeial manufacturing environment before their use in the...
Reusable Advices For Reusable Medical Devices
Ensuring that reusable medical devices can be properly cleaned, disinfected, and sterilized is crucial for patient safety...
What is Cytotoxicity
In this episode, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel. Dr....
Cleaning Validations for Newly Manufactured Medical Devices
The implementation of ISO 19227:2018, which addresses the cleanliness of orthopedic implants, has set a new standard...
Intro to Pre-Clinical Testing and Biocompatibility
In this episode of the RCA Podcast, host Brandon Miller is joined by Dr. Matthew Jorgensen and...
Quality Culture at the Crossroads: Building a Culture of Quality for Increased Success
In this webinar, Susan Schniepp, distinguished fellow at Regulatory Compliance Associates®, will delve into effective approaches for...
2022 Industry Outlook Medical Device
In this episode, host Brandon Miller is joined by Seyed Khorashahi and Thor Rollins to explore the...
Cytotoxicity Failure What Now
Cytotoxicity testing is a critical endpoint for all medical devices that come into contact with patients or...