Stop Asking Why

Sometimes the "why" question should be broken into smaller parts. by Harish Jose  Senior Quality Engineer ASQ CRE, ASQ CQE, ASQ CS...

Why We Trek to Trade Shows

You'll see MasterControl exhibiting at  more than 10 trade shows this year.  MasterControl staffers frequently address  industry confere...

Leveraging Quality Management Systems to Visualize and Mitigate Risk at a Cross-Enterprise Level

Learn to use a quality management system at a  cross-enterprise level during the Proactive  GCP Compliance Conference MasterControl Expert A...

How to Explain Your Quality Job to Young Kids in 4 Steps

First-graders learn the concept of quality  through a paper airplane building exercise. by Lillian Erickson Global Quality Manager, MasterCo...

Quality by Design Part 1: You Can't Design Something You Don't Understand

If the cost of poor quality is like an iceberg, the obvious penalties are a lot less scary than what lies below the surface. by Beth Pederse...

The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

The FDA is working with a wide variety of  stakeholders  to identify  and promote practices  that will result in higher quality devices. by...

Steak, Peas, and Doughnut Holes

Continuous improvement can lead to great success but your efforts must be focused. Food for Thought about Continuous Improvement by Curt Por...

When Is A CRO Not A CRO? (And why does that make enforcement hard?)

  It looks like a CRO. It sounds like a CRO. But is it really a CRO? by Jamie Colgin Colgin Consulting What do the following types of compan...

One Q & a Lotta A’s about SOPs for Research Sites

SOPs or work instructions--- which does a clinical research site need? by Laurie Meehan Social Media Manager Polaris Compliance Consultants,...

People Don’t Fail, Processes Do

When a situation goes wrong,  look at your process and ask why. by Terry Smith Lean Enterprise Institute Lean isn’t only a mindset. It give...

How to Respond to FDA Inspection Observations, Including Those You Dispute

by Martin Browning, President, EduQuest, Inc.  FDA expert investigator and rule-maker for 22 years Although FDA is strapped with limited r...

Do You Really Want to Be An Executive In An FDA-Regulated Company?

If you don't want a visit from the  Department of Justice, pay attention  to the new enforcement policies  the DOJ is following. by Jam...

6 Ways Quality Managers Can Build a Culture of Quality

Agreeing on a definition of quality is just one way to foster a culture of quality in your company. by Beth Pedersen, Marketing Communicat...

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...

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          ...

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...

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...

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...

Holistic CQMS: The Modern Model of Clinical Trial Management

Best clinical quality management practices  can only be achieved when an overarching  culture of quality exists organization-wide. by Jam...