Big Changes for ICH GCP & EU Regulations

Changes are being proposed for international  clinical research, including the European Union.   How and when will they affect your work? by...

5 Lessons I Learned from a Successful ISO 9001:2015 Certification Audit

Effective risk management requires an  in-depth and sometimes painfully honest assessment  of your processes and your areas of risk.  by Lil...

A Season for Giving That Lasts All Year

 During the holidays and all year round, a gift from the heart is the best gift of all. by Beth Pedersen, Marketing Communications Speciali...

Using Quality by Design to Improve Manufacturing

Process control and process improvement  are important parts of life cycle management. by Ronald D. Snee, PhD Snee Associates, LLC          ...

Preparing for ISO 13485:2016 Changes

by James Jardine, Marketing Communications, MasterControl As 2015 comes to a close, medical device manufacturers throughout the world share ...

6 Lessons that Quality Managers Can Learn from ‘Star Wars’

by David R. Butcher Marketing Communications, MasterControl Beginning with A New Hope nearly 40 years ago, characters in the epic  Star War...

The Drug Supply Chain Security Act: Current Impact

The Drug Supply Chain Security Act is the most  complex pharma track and trace law ever passed. by David Dills Sr. Consultant, Regulatory ...

How Performance Excellence Helps Broaden the Horizons of Quality

Where is your focus---on the quality of business or the business of quality? by Mickey Garcia, Segment Manager, Medical Devices, MasterContr...

The Mysterious "No Fault Found"

Ferreting out root cause can explain the  reasons behind a "no fault found" condition. by Harish Jose Senior Quality Assurance Eng...

Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

An auditor's goal is to confirm the trial runs  in a way that ensures the safety of the subjects,  protects their rights and generates r...