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-B
$547.00
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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.
Listeners to Risk-Based Verification and Validation 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