Essentials of Validation - IQ, OQ, PQ - Webinar

  • ID: 4428084
  • Webinar
  • 90 Minutes
  • NetZealous
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Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

Why You Should Attend: Failure to validate is a significant cause of 483 observations. Even worse, it can result in customer complaints, adverse events, and even recalls. In this webinar, you’ll learn how to avoid these problems and use validation concepts to ensure process stability and control. You’ll learn the benefits and impacts of validation and how it can benefit your customers and your business. We’ll cover tools and techniques that can help you successfully validate your processes.

Areas Covered in the Session:
Purpose, Scope, and Benefits of Process Validation
FDA Expectations, Regulations
Lessons Learned and Enforcement Case Studies
When to Verify and Validate
Process of Verification and Validation
Linkages to your Quality System
Master Validation Planning
Best Practices
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  • Susanne Manz Susanne Manz,


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  • Code Developers working on Medical Applications
  • Regulatory Affairs Associates
  • Health Care Software Marketing Associates
  • QA associates for firms that are developing/revising Medical Software
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