Since the final rule was issued in June 2008 by the FDA (21 CFR 111),for the manufacturing and...

With the ever-increasing competitive landscape for Life Sciences Products, be they...

Commercialization of products that are destined for US market distribution, whether manufactured...

Today Pharma 4.0 is all the rage. Like other fads and buzzwords, it is being banded around like...

The documentation process is an extremely important feature in cGMP compliance. That said, there...

The challenge for quality in manufacturing pharmaceuticals is a constant battle. The need to...

In addition to the Quality Management System approach and application of risk principles, a way to...

In any industry sector, but specifically that dealing with Life Sciences one is faced with the...

Leadership in today’s environment is becoming a more complex proposition than it has been in the...

Managing inspections is a very nervy process but if planned out carefully may not be as daunting...

With the evolution of products in the tissue regeneration arena, we are seeing a concomitant...

As the number of therapeutic targets continues to ramp up both in terms of numbers and complexity,...