Device Makers Urged to Ramp Up Their Security Efforts

Device makers aren't doing enough to protect their data or devices,   experts agree. by Lisa Weeks, Marketing Communications Specialist,...

4 Reasons Why Document Review is Crucial to Compliance

When was the last time you reviewed  your quality documents? by Cindy Fazzi Editor, MasterControl Insider When was the last time you reviewe...

Study: Doctors are Ready to Embrace mHealth Tools

More than half a billion smartphone users  are expected to be using mobile  health apps this year by Lisa Weeks, Marketing Communications Sp...

How 3-D Printing is Revolutionizing Medical Devices

Scientists think it will be possible to  print a 3-D heart in 3 to 5 years' time .  by Lisa Weeks,  Marketing Communications, MasterCont...

7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

Human error is responsible for more than  80 percent of failures and defects.  by Ginette Colazzo President of Ginette M. Collazo, Inc. Huma...

FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users

How are human cells, tissues and tissue-based products  (GCT/Ps) made from adipose  tissue regulated by the FDA? by Stacie L. Ropka  and Cha...

Tales from the Front

Sometimes it’s your company that forces  a new direction during the inspection,  sometimes it the auditor. Sometimes it’s both. Adventures o...

EU vs US: What are the New Track and Trace Requirements?

The European Commission and the FDA are fighting  counterfeit medicines through traceability  requirements in the pharmaceutical supply chai...

Don’t Call Me Jim Cramer but Here are My Top 5 Pharma Trends

Pharmaceutical production costs are rising  because companies  have more hurdles  to pass during the testing phase. by Lane Hirning Product ...

CAPA and Root Cause Analysis for the Food Industry

Can you find the root cause for the chaos in this kitchen?  Unless you identify the root cause of a problem, you cannot resolve it.   By Dr....