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Risk-Based Verification and Validation to Meet FDA 820.75 and ISO 13485 Requirements: Best Practices to Move from a Classic Approach to a Risk-Based Approach
A high volume of warning letters and high-profile recalls can be traced to a lack of sufficient verification and validation (V&V) planning.
But frustrated device V&V professionals constantly throw their hands up and ask, “How can we verify and validate everything? It would take eons to complete.”
The FDA and international regulators have heard the calls and have developed enhanced risk-based validation guidelines. The idea is that, of course, you can’t verify and validate everything. The key is to quantify the inherent risk in a process or software system and apply validation and verification resources based on its risk profile.
More risk equals more time and resources. Less risk equals less time and resources.
Sound easy? Sure, but given the steady drumbeat of warning letters and 483s, it’s not.
The FDA leaves it up to companies to determine the appropriate level of testing for processes, systems and software based on the definition of validation that requires “establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.”
But serious questions remain. Such as:
If you’re not able to answer these questions for yourself and your management, you need an expert. Don’t delay.
Risk-Based Verification and Validation listeners will learn:
This audio CD/Transcript is a must for professionals in the device industry, including:
John Lincoln, Partner, J. E. Lincoln and Associates LLC
Mr. Lincoln offers more than 30 years of experience working in FDA-regulated industries, especially medical devices. He has specialized knowledge in engineering/product development, quality and regulatory affairs. Mr. Lincoln is one of the few regulatory consultants who have also designed, piloted, set up production facilities, validated, and brought to market medical devices. He has worked in R&D, engineering, manufacturing, quality and regulatory, providing a unique insight. Mr. Lincoln serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance and Intermountain Biomedical Association. He is a graduate of UCLA.
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