A Strategic Road Map - GUIDANCE (Technical Series on Process Validation Principles and Practices Book 1)

This e-book - A Strategic Road Map, is the first in a series under the title: Technical Series on Process Validation Principles and Practices. Other e-books will be added to the series based on user feedback, updates from the regulatory agencies, and technological and methodological developments in the medical device manufacturing field.

The e-book introduces medical device manufacturing process validation road maps by first visiting the issues that face many medical device manufacturers today in the area of process validation. This is followed by a step-by-step illustration of the process validation journey that runs from the process design stage through manufacturing process qualification to continued process verification.