Live Webinar Validation Concepts for Medical Devices By Susanne Manz
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
"Hear By Susanne Manz who holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality."
Validation is an important element of the Quality System Regulations and ISO13485.
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 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 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.
• 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 will Benefit
• Manufacturing Engineers
• Process Engineers
• Quality Engineers
• Engineering Managers
• Quality Managers
• Compliance Specialists
Industries who can attend
This 90-minute online course is intended for professionals in the in electronics, automotive, retail, and medical device Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel