OMG! The FDA Is Keeping Up With Kim Kardashian, Too

The reality star promoted Diclegis on Instagram  without mentioning its side effects.  By Alex Butler, Product Manager, Life Science Applica...

FDA Requests Public Input on Quality Metrics Guidance

Which quality metrics are you tracking  for audits and inspections?  The FDA is seeking input  on the types of data that contribute to a ...

Three Things I’ve Learned about Quality Professionals

Quality professionals attending the 2014  MasterControl Masters Summit take a break  from educational sessions to enjoy a  Chinese auction, ...

Infographic: FDA Inspections By The Numbers

During the last 15 years, FDA has gradually  ramped up the number of annual inspections. by Tony Chen CEO and Co-Founder of FDAzilla Up un...

Education And Corrective Actions: The Solid Foundation Of Food Safety Culture

A good food safety culture really means that  everyone within your organization shares  the same mindset, values, ambitions,  and practices ...

ISO 9001:2015 – The Best Thing for Top Management Since Ambien

Are you a sleepless manager? Maybe you'd  benefit  from a review of the changes in the  new version of ISO 9001:2015. by Matt Leiphart C...

Reimbursement: A Medical Device Company's Worst Nightmare?

Are you losing sleep over the ACA's    value-based reimbursement model, too?  by Lisa Weeks, Marketing Communications Specialist, Master...

Unique Device Identification (UDI): Much More Than Just a Label

Unique device identification (UDI) will not only change  the face of your med device labels, but it will  also affect processes spanning y...

Why a Zombie Apocalypse Would Be Unstoppable with a QMS

Would zombies be more successful  at world domination if they used an  electronic quality management system? by Marci Crane Localization Man...

What Quality Really Means: Three Key Principles

It’s important to be mindful of quality in both small  and big ways, especially if your organization is regulated. by Lane Hirning Product M...