FDAnews Announces Process Validation for Devicemakers: Concepts, Methods and Models Management Report
Summary
Process Validation for Devicemakers: Concepts, Methods and Models is a must to ensure medical devices are compliant. This report outlines inspection priorities and it explains the unique challenges of software validation step-by-step. Process Validation for Devicemakers will keep the validation program comfortably ahead of the regulators by explaining: • The concepts of process validation, including the distinction between product verification and process validation • When and how to validate a process • What to expect during an FDA inspection • How to set a maintenance schedule and use Total Productive Maintenance • How to use statistical tools, including the process model, capability and performance indices and attribute-acceptance sampling • How to use operational qualification (OQ), including design transfer and challenge tests • The role of performance qualification (PQ), including process monitoring and revalidation • Production issues for validated processes, such as hazard analysis and critical control points, and risk management The report includes copies of FDA resources and guidance documents, a variety of checklists, decision trees and statistical analysis tools to help you develop a robust and compliant validation program. Validation of processes, equipment and software is vital to a medical device’s quality management — and to compliance. Pharmaceutical and medical device professionals rely on FDAnews print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDAs complex and ever-changing regulations