Health

Concepts, Methods and Models Management Report

Leave a comment


WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

Process Validation for Devicemakers:

Concepts, Methods and Models

https://www.fdanews.com/products/category/223-device-books/product/61151

Does one’s process validation program stand up to FDA scrutiny? Process Validation for Devicemakers: Concepts, Methods and Models is a must to ensure medical devices are compliant.

This management report walks one through each step of the validation process. It provides the information needed to make decisions along the way. And it presents validation strategies, methods and tools to use to ensure compliance. 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

  • Regulatory requirements

  • What to expect during an FDA inspection

  • The role of installation qualification (IQ)

  • 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

  • An 11-step process for validating device software

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. Take control today.

Management Report Details:

Process Validation for Devicemakers:

Concepts, Methods and Models

https://www.fdanews.com/products/category/223-device-books/product/61151

Price:

$397

Easy Ways to Order:

Online: https://www.fdanews.com/products/category/223-device-books/product/61151

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

Share article on social media or email:

Leave a Reply