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...

The SCIO Concept: How to Conduct Cost-Effective Clinical Trials

For the past 20 years, the cost of new drug  development has risen at a rate  that was 7.4%  higher than inflation, and clinical trials bear...

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...

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...

CLIA vs QSR (What You Don’t Know Can Hurt You)

The Clinical Laboratory Improvement Amendments (CLIA)established quality standards to ensure the accuracy, reliability, and timeliness of pa...

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...

How to Ensure You are Following the ISO 9001 Certification Process

These tips help ensure you are  following the correct processes  for successful ISO certification. by Stuart Patch Content Writer Compass As...

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          ...

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 ...

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...