General GxP (GxP)

The Fundamentals of Inspection Readiness

The Fundamentals of Computer System Validation

The Fundamentals of GxP in a Regulated Environment

What is Quality Risk Management (QRM)?

What are CAPA’s?

Why are Regulatory Inspections So Critical?

What are Deviations?

1955 – The Polio Vaccine – The Cutter Incident

1938 – Sulfanilamide, the Elixir of Death

1930 – Lubeck BCG Vaccine