ProDisinfectant Efficacy Testing Coupon/Carrier Method
Disinfectants must be qualified on the surfaces within a pharmacopeial manufacturing environment before their use in the...
Archives: Courses
Product Adoption for Ethylene Oxide Sterilization
Changes to the design of an existing product or the adoption of a new product into a...
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...
Sterility, Manufacturing and Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals
The biopharmaceutical sector is experiencing rapid changes, transitioning from monoclonal antibodies to advanced therapies such as Cell...
Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges
Flexible bag systems for large volume parenterals (LVPs) are subject to stringent regulatory oversight for extractables and...
Product Safety Future State of Sterility Assurance and the Role of Terminal Sterilization
Sterilization is a critical step in the pharmaceutical drug development process to ensure overall safety. Regulations are...
Upcoming Changes to Cleaning Validations for Reusable Medical Devices
For the past decade, AAMI TIR30 has served as a key guidance document for the cleaning validations...
Assessing the Safety of Extractables and Leachables for Drug Products: When and How?
In this insightful webinar, Kevin Breesch of Nelson Labs will address the significant challenges associated with toxicological-safety...
EO Sterilization: Considerations for Neonate Products and Medical Devices & ISO 10993-7
Ethylene oxide (EO) sterilized items are life-saving and critical devices that undergo sterilization in highly regulated environments,...
Laboratory Out of Specification Investigations
In this episode, host Brandon Miller is joined by Walter Mason, Senior Director of Quality Control and...
Case Study Quality Complaint Investigations
In this episode, host Brandon Miller is joined by Walter Mason, Senior Director of Quality Control and...
Extractables and leachables testing of a combination device: testing in between regulations for pharmaceutical products and medical devices
Extractables and leachables (E&L) testing of combination devices requires a specific study setup that differentiates from a...
Case Study: Warning Letter Remediation
In this episode, host Brandon Miller is joined by Steven Lynn, Executive VP of Pharmaceuticals at Regulatory...
Understanding the Power of the FDA Pre-Sub: Tips for a Successful Meeting
The submission process to the FDA can be a stressful and uncertain time for a medical device...