January 2015 Posts

Leverage Your CAPA Process to Build a Culture of Quality (Free E-Book)

Leverage Your CAPA Process to Build a Culture of Quality (Free E-Book)

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

The Corrective and Preventive Action (CAPA) process is at the heart of your quality and compliance system. When properly implemented, CAPA resolves and prevents critical problems and also keeps you in compliance with FDA regulations. But year after year, lack of CAPA procedures and documentation make the list of top FDA 483 observations. The FDA closely monitors the CAPA process, which is why you need to have a handle on it as well. (more…)

UDI Resolutions: Ringing in the New Year with Compliance

UDI Resolutions: Ringing in the New Year with Compliance

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Every year when January rolls around, there’s a cultural shift toward new beginnings and starting the year off right. Countless articles are published about making New Year’s resolutions, and gyms are packed with athletic hopefuls. People resolve to make self-improvements, even in their daily work lives.

A new year can signify the beginning of new projects or initiatives in the workplace, too. This typically includes setting goals to be more effective, efficient and productive than the prior year. (more…)