GMP ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 1 - With Checklists and Software Package) : With Checklists (6th Edition)

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 are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format. Volume one 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. Content: Chapter 1 Regulatory Considerations -- chapter 2 Quality Audits -- chapter 3 Internal Facility Audits -- chapter 4 Supplier Audits -- chapter 5 Contractor Audits -- chapter 6 Product Audits -- chapter 7 QSIT Audits. Comprehensive in its coverage, this practical guide is an invaluable resource that offers effective training for new auditors on new standards and regulations.