Gmp/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package): With Checklists and (Hardcover, Revised)

Volume 1 includes checklists for: Internal Device Manufacturer/Developer, Internal Drug Manufacturer/Developer, Contract Device Manufacturer/Developer, Contract Drug Manufacturer/Developer, Contract Software Developer, General Supplier, Chemical Supplier, Printed Material Supplier, Electronic Component Supplier, Simulated QSIT Audit (FDA Approach), and New Product Market Launch - all referenced to the relevant FDA regs, EC and IPEC guidelines, and ISO/BSI standards. It also includes complete explanation of audit types, their advantages/disadvantages, do's and don'ts for auditors and guidance for audit preparation, performance, conclusion, report derivation and follow up activities. The Software Package consists of the checklists in electronic format that permits users to: load them onto computers and use as is, modify them by adding users' own questions, complete the checklists and store as an electronic record, and print all checklists.