Reprocessing Validations Flexible Endoscopes and AAMI ST91
The newly revised AAMI ST91:2021 standard provides comprehensive guidelines for the processing of flexible and semi-rigid endoscopes...
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Parenteral Drug Development Exploring the Potential Benefits of Terminal Sterilization
In this insightful webinar, originally presented at Pharmapack Europe 2022, S. Ross Tsakas, Pharmaceutical Segment Leader at...
DHF and Design Control
In this episode, host Brandon Miller is joined by Jessica Schafersman, a Biomedical Engineer, Project Management Professional,...
Outsourcing and Staff Augmentation
In this episode, host Brandon Miller is joined by Erica Porcelli, CEO of Regulatory Compliance Associates (RCA),...
What is ISO13485
In this episode, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory...
FDA Regulation of Hand Sanitizers – What Testing Should be conducted to Markt a new Hand Sanitizer?
All hand sanitizers, whether used by consumers or healthcare professionals, are considered over-the-counter (OTC) drugs regulated by...
Biocompatibility Fundamentals for Medical Devices
This comprehensive eBook serves as an essential guide for professionals involved in the design and manufacture of...
The Necessity of Extractables and Leachables Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.
When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), a fundamental question arises: How...
Setting up Extractables & Leachables Studies for Small Volume Parenteral Applications
In this presentation at the 2022 Nelson Labs Virtual Symposium, we will cover the general principles of...
