Blogs
Accelerating Batch Record Reviews With Electronic Batch Records
By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc. Is your company still using paper batch records to manufacture your commercial products? In 2024, there are many affordable solutions to help improve accuracy, reduce...
Quality Systems, Part 2: Developing Effective CAPAs
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...
What is GxP in pharma?
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...
Medical Devices-EU MDR Compliance
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,...
Quality Systems, Part 1: Deviation Management and Investigations
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...
The Criticality of Supplier Management and Keys to Improvement
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...
EU MDR vs. U.S. QSR and the Role of Digitization
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...
Life Sciences Start-Ups: What You Need to Know About Phase Appropriate Quality Requirements
By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc., and Paul Andrea, Independent Consultant, MWA Consulting, Inc. Whether your start-up company makes pharmaceutical products, biologics, or medical devices, you all have one thing in...
Conducting Remote GxP Audits: Three Keys to Success
By Paula Pilecki, Sr. Director of Project and Audit Management, MWA Consulting, Inc. Introduction The COVID-19 pandemic created unprecedented challenges for quality and compliance professionals in the pharmaceutical, biotech, and medical device industries. Staying on...