1 Table of Contents: “...) -- Chapter 4 Developing a practical audit system for a pharmaceutical industry based on six system inspection...”

2 Table of Contents: “... -- Uncertainty measurement -- Sampling strategies -- Outsourcing -- Process -- Audit Check List -- Documentation...”

3 “...). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies...”

4 “... nuances but rather to be an educational text on conducting defendable and auditable science to support...”

5 “... are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP...”