Process Validation for Devicemakers: Concepts, Methods and Models
Process validation is key in compliance. But do you know the difference between verification and validation? Between qualification and validation? And how do you use risk-based planning to determine what needs validating?
When you know what the FDA and other regulators expect from your device validation program — and when you understand the methods and tools they’ll use to conduct validation — you’ll stand up to scrutiny and be compliant. Process Validation for Devicemakers: Concepts, Methods and Models brings you all that and more.
This management report walks you through each step of the validation process. It provides the information you need 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 you and your validation program comfortably ahead of the regulators.
Key Report Highlights:
- 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
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 your device’s quality management — and to compliance. Take control today, with Process Validation for Devicemakers: Concepts, Methods and Models. Order your copy now.
Who Will Benefit
- Project managers involved in design and development
- Design engineers
- Quality engineers
- Manufacturing engineers
- Quality auditors
- Production managers
- Quality or regulatory staff assigned to complaint, CAPA or MDR management
- Risk management specialists
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