Validation & Verification: Key Components for Quality Assurance of Medical

Description:

Verification and validation are important elements of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn which processes needed to be validated and what steps are required 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. A validated process is optimized ensure predictable and improved quality and compliance results.

Why Should You 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 optimize processes ensuring stability and control. You’ll understand 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 Webinar:

• Regulations and regulator expectations
• Purpose, scope, and benefits of process validation
• Lessons learned and enforcement case studies.
• Common problems and easy solutions
• Important documentation
• When to verify and when to validate
• Steps for successful validation
• Linkages within your Quality System
• Best Practices
• Preparation for FDA inspections

Who Will Benefit:

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