Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these

part I|1 pages

Quality Audit Purpose and Practice

chapter 1|4 pages

Regulatory Considerations

chapter 2|5 pages

Quality Audits

chapter 3|7 pages

Internal Facility Audits

chapter 4|7 pages

Supplier Audits

chapter 5|3 pages

Contractor Audits

chapter 6|2 pages

Product Audits

chapter 7|5 pages

QSIT Audits

part II|1 pages

Quality Audit Checklists

chapter |24 pages

General Supplier Audit Checklist

chapter |38 pages

Bulk Chemical Supplier Audit Checklist

chapter |26 pages

Printed Material Supplier Audit Checklist

chapter |19 pages

New Product Market Launch Checklist