Liza Nelson

Executive Summary Cisco Vicenty tells how the US agency will structure its pilot program for device-makers with less-than-stellar FDA compliance histories that want to use the CMMI maturity model framework to improve the quality and maturity of their manufacturing organizations – and clean up their FDA compliance problems along the way. The FDA – which…

Over the last two decades, the global pharmaceutical industry has been working to secure the supply chain, through the development and implementation of serialization standards in over 50 markets. Although outliers remain, in general, pharmaceutical products in the impacted markets will have unique identifiers in an attempt to secure the legitimate supply chain from infiltration…

“Flawless” may not exist on the plant floor, but reviewing your quality process can save money and lives Many years ago, while working on developing a Quality Management System for a large automotive company, we heard a story about how the company had perfected Corrective Action, Preventive Action (CAPA). The company had a clearly defined,…

Few industries are scrutinized by regulators as carefully as the pharmaceutical industry. Manufacturers of medicine should, for example, be able to demonstrate at any time how they meticulously follow the Standard Operating Procedures (SOPs), and how patient safety is never compromised. But how do you ensure you have the most current, accurate, and complete data…

An Automation Engineer utilizes technology to improve, streamline and automate a manufacturing process.  They are responsible for planning, implementation, and monitoring of such technology. Let’s take a closer look at the details of automation and the role of an Automation Engineer. What is Industrial Automation Exactly? At its most basic level, automation consists of three…