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...
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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...