Risk Management in Clinical Research: Process and Application

One aspect of quality involves how risks are approached  and managed throughout the course of a clinical trial by Emily Haglund Clinical Aud...

Med Device Excise Tax Debate: Let Your Voice Be Heard

After two years of implementation, we are now  getting a chance to evaluate the Medical Device Innovation  Protection Act's impact on th...

Getting Ready for ISO 13485:201X (Part 1)

The quality management standard for med devices is changing. by Lisa Weeks, Marketing Communications As most of you know, ISO 13485–Quality ...

Five Steps to Building Process Efficiency with Your Supplier

As supplier activities become more complicated,  there's a new role for a supply chain liaison consultant  who can facilitate activities...

Setting an Organization's Risk Management Context

There are five fundamental questions  you need answered to manage risk by Rod Farrar Director, Paladin Risk Management Services There is con...

What Does Risk-Based Monitoring Mean for QA Auditing?

What does risk-based monitoring mean for quality  assurance teams who audit clinical studies? by Laurie Meehan I nternal Project Manager, Po...

Enter The Digital Risk Officer

Meeting the new digital risk officer. by Nicola (Nick) Sanna President, Digital Risk Management Institute In the brave new world of digital ...

Risk Management: A Primer for Lean Quality Assurance

Managing risk across an organization is now a critical skill  that should be fully integrated with other business functions  such as financ...

Enjoy a Quality New Year!