3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

Overview:

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need 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 seminar, 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. This seminar will cover tools and techniques that can help you successfully validate your processes. Validation can help you to optimize your processes with resulting improvement in predictability, consistency of outputs, and business results.

Areas Covered in the Session:

• Purpose, scope, and benefits of process validation
• FDA Expectations, Regulations
• Lessons learned and enforcement case studies
• Common problems and easy solutions
• When to verify and when to validate
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Steps and checklists for validation
• Documentation
• Linkages within your Quality System
• Master Validation Planning
• Best Practices
• Inspection Preparedness

Who Will Benefit:

• Manufacturing Engineers
• Process Engineers
• Quality Engineers
• Design Engineers
• Engineering Managers
• Quality Managers
• Auditors
• Compliance Specialists