"Every 483 Observation Has A Training Component"
“Every 483 observation has a training component.” Truer words have never been spoken—I only wish it was me who said them. An FDA inspector I heard at a conference almost 15 years ago made this statement, and it forever changed how I look at 483 observations. I’ll admit up front that I have a bias towards training—after all, it’s what I do. Others don’t necessarily share that bias, being that often training isn’t done well, isn’t timely or effective, isn’t always meaningful. I’ve heard the arguments and can even agree with some of them. But let’s set that aside for now and look at what the inspector meant.
WHITE PAPERS & CASE STUDIES
Troubleshooting Load Cells
When we have a problem with our weighing system and have to do some troubleshooting, where do we start? A good place to start is the load cell. By Dominic Barbuto, Sartorius Intec
Is Portable Tank Weighing Possible?
Not only is portable tank weighing possible, but so is highly accurate portable tank weighing. In order for a portable tank system to have high system accuracy, it must have a rigid foundation that does not flex or bow, regardless of external influences. By, Steve Watson, Sartorius Intec
Automated Solid Dose Inspection: A Flexible Alternative
This article will discuss some of the trends in automated solid dose inspection, the benefits of a low-cost, portable and product-flexible platform, what to look for when evaluating an advanced solution, and it will also describe the new available technology.
Exceeding GMP Of Medical Devices At Each Step In The Production Continuum
Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.
Pharmaceutical Company Cuts Packaging Costs
In tough economic times, First Priority, manufacturer of generic veterinary pharmaceutical products, decided it was time to take a hard look at where they could cut costs without compromising on efficiencies and quality of their products.
Be In Control Of Product Quality – Do Not Just Rely, But Understand
Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC