By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc. In Quality Systems, Part 1: Deviation Management and Investigations, we learned about deviation management and investigations. In this second part of the series, we will...
By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc. What is GxP in pharma? If your organization operates in the pharmaceutical industry, encountering GxP quality requirements is unavoidable. In fact, embedding strong and repeatable...
By Jason Jegge, Quality and Regulatory Consultant, MWA Consulting, Inc. In follow-up to the How to Transition to the EU MDR Webinar on March 30, 2023, we would like to detail some of the transition highlights and considerations for your attention. First and foremost,...
By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc. Performing deviation investigations and writing reports can be a daunting task for busy professionals. This overview of deviation management will describe how to initiate...
By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc., and Myrna Russell, Director of Quality and Audit Management, MWA Consulting, Inc. Medical device supplier quality management can be daunting for any quality group, especially when...
By Jason Jegge, Quality and Regulatory Consultant, MWA Consulting, Inc The differences in the ways medical devices are regulated in the U.S. and Europe are subtle but important to understand. This article examines those differences and explains how digitization...
