Risk-Based Verification and Validation

Risk-Based Verification and Validation to Meet FDA 820.75 and ISO 13485 Requirements - Webinar CD/Transcript

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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:

  • What is the difference between classic approach validation and risk-based validation?
  • Why does the FDA think risk-based validation is a big deal?
  • How will switching to risk-based validation save time and money?
  • If my quality appears satisfactory, why do I need a Validation Master Plan?
  • What’s with all the Qs? How do I incorporate DQs, IQs, OQs and PQs?

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:

  • Process validation regulatory requirements included in QSR 820.75 and ISO 13485
  • Validation vs. verification: understanding the critical differences
  • Defining key concepts: Installation Qualification (IQ), Operational Qualification (OQ) and Production Qualification (PQ)
  • Creating a risk classification scheme to categorize devices according to their potential risk
  • Risk management techniques to use during the qualification stage to revalidate change control activities
  • How to maintain a state of control after validation activities are complete

This audio CD/Transcript is a must for professionals in the device industry, including:

  • Process Owners
  • Quality Managers
  • Quality Engineers
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Manufacturing Engineers
  • Process Engineers
  • Development Engineers
  • Project Managers

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.