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...

Laboratory compliance and efficiency can have a major impact on the success of the company to...

One of the outcomes from a poorly handled 483 response is that the severity of the enforcement...

Upon inspecting your pharmaceutical facility, the FDA will issue a 483-observation report if there...

The development of a strategy for the commissioning of facility and equipment systems to support...

Key performance indicators (KPI’s), are very important mechanism for promoting continuous...

Nigel with Chris Macklin today at the American Outsourcing Event, Crown Plaza Hotel, Cherry Hill ...