Process and Design Validation for Devicemakers: Concepts, Methods and Models
Before a new medical device can go to market, a devicemaker must provide evidence to the FDA that the product meets its design requirements and that its manufacturing processes can consistently comply with quality standards — a concept known as validation.
On top of this FDA scrutiny, validation can take many forms; devicemakers need to understand all of them to comply with agency regulations.
Process and Design Validation for Devicemakers: Concepts, Methods and Models is here to help you sift through any quality management confusion and understand what regulators expect when you validate your new device.
Newly updated to include the latest inspection and enforcement trends for validation programs as well added content on device design, Process and Design Validation for Devicemakers: Concepts, Methods and Models walks you through each step in the validation process. The authors outline strategies, methods, tools and inspection priorities. This step-by-step explanation also includes copies of guidance documents and other resources from the FDA, as well as a variety of checklists, decision trees and statistical analysis tools to help develop a robust and compliant validation program.
- Decipher the difference between product verification and process validation
- Decide when and how to validate a process with the correct regulatory requirements
- Learn how to prepare for an FDA inspection
- Understand installation qualification (IQ), operational qualification (OQ), including design transfer and challenge tests, and performance qualification (PQ), including process monitoring and revalidation
- Discover how to use statistical tools, including the process model, capability and performance indices, and attribute-acceptance sampling
- Determine how to set a maintenance schedule and use Total Productive Maintenance
- Gain an awareness of production issues for validated processes, such as hazard analysis, critical control points and risk management
Acquire best practices for your process and design validation today with Process and Design Validation for Devicemakers: Concepts, Methods and Models.
About the Contributors
Dan O’Leary is president of Ombu Enterprises (retired), a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. O’Leary has more than 30 years of experience in quality, program and operations management in regulated industries, including medical devices, clinical labs, aviation and defense.
John E. Lincoln is a partner at J.E. Lincoln and Associates and has more than 30 years of experience as an FDA consultant. He has previously held positions in manufacturing, engineering, QA, QAE and regulatory affairs, as well as director of R&D.
David Petrich is vice president of quality and regulatory at the Landrich Group and former quality site head and senior director of design quality assurance at Roche Molecular Systems. He has been a quality and regulatory executive for more than 20 years, leading cross-functional teams to develop, manufacture and commercialize in vitro diagnostics and medical device products.
Who Will Benefit
- Project managers involved in design and development
- Design engineers
- Quality engineers
- Manufacturing engineers
- Quality auditors
- Production managers
- Risk management specialists
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Dan O’Leary, John E. Lincoln and David Petrich
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