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,...

Today more than any time in the past it is vital that we create customer value. How we do that...

Part 3 The QC Laboratory The laboratory is a special piece of the total site audit and can often...

Part 2 The Process Area Important as one starts to review the process area compliance is to...

Part 1. The Warehouse. Like most things in life, starting with good preparation is the best way to...

Today more than ever, Data Integrity has become a significant factor in being a compliant...