Validation is an important element of the Quality System Regulations and ISO13485. This course will cover 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. We’ll discuss the top mistakes that companies make and how you can avoid them.
Why You Should Attend:
Process validation is required per regulation to show regulatory authorities that a process consistently produces a result meeting its predetermined specifications. If not performed properly, process validation can result in delays in product development, or even in product quality issues.
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 how to conduct process validations 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
Who Should Attend:
Manufacturing Engineers
Process Engineers
Quality Engineers
Engineering Managers
Quality Managers
Auditors
Compliance Specialists
Validation Specialists
Methods Development Scientists
QC Analysts