Quality & Regulatory Compliance Issues in the Medical Device & Diagnostics Industry

It’s the piece of paper that you never want to see come across your desk. You’ve received a warning letter or an FDA 483 and you’re now being faced...

Regulatory Compliance and Quality professionals in the Life Sciences industry face constant challenges on a daily basis. Carrying the critical...

The need to supplement your employees with external resources is very common in the pharmaceutical and medical device industries, particularly...

Spotlight on Innovation: Tosoh Bioscience

Since 1987, Tosoh Bioscience has repeatedly paved the way in bioseparations, firmly establishing itself as...

What is quality?  According to Merriam-Webster, quality is defined as “degree of excellence.” To those working in Quality in the pharmaceutical and...

How to Implement Continuous Improvement on the Manufacturing Floor

With the ever-increasing demands and pressures from Executive Leadership Teams...

5 “Don’ts” when it comes to responding to a Form 483

As a leader in Quality and Regulatory Compliance in the Life Sciences industry, you are...