A Guide to GMP Investigations and Corrective Actions: Clear and Simple (publication planned for 2016)
Unwanted quality events and deviations occur in even the best organizations. When they happen, investigations help to identify what caused the event and provide information on options for how to prevent a recurrence. This book provides information on the regulatory expectations for such investigations and reports, along with tools that can be used to more effectively and efficiently determine the root and contributing causes. Other topics include “human error,” guidelines for interviewing, and integrating risk management into an investigation program. Sample worksheets, templates, and checklists are included.