FDA White Papers & Case Studies
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Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids
10/17/2018
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.
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The Case For A Facility Monitoring System
3/27/2018
Facility monitoring software with OPC UA client/server functionality makes great business sense. Learn how monitoring leads to reduced waste, improved yield, higher quality, and increased profits.
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Enhancing Process Safety In The Pharmaceutical Industry
3/23/2018
This paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system.
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Security Of Pharmaceuticals: A Comparison Of EU And US Standards
2/27/2017
Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However, the US and Europe are also a lucrative target for drug crime.
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The First Step To Navigating Your Combination Product's Regulatory Pathway: PMOA
4/5/2016
The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.
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Exceeding GMP Of Medical Devices At Each Step In The Production Continuum
6/8/2014
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.
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3 Tips For Safe, Secure Healthcare Shipping
7/12/2013
All businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical
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Improving Quality Processes For Medical Device Development And Manufacturing
3/21/2013
Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. By Mike Kuehne, ACSYS, Inc.
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Selecting, Implementing, And Using FDA Compliance Software Solutions
2/28/2013
We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”
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eTMF And The eClinical Universe
2/21/2013
How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.