HR Training 2020 - Essentials of Validation – IQ, OQ, PQ

Overview:
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
Common problems
When to verify and when to validate
Process and steps for validation
Linkages to your Quality System
Master Validation Planning
Best Practices
Who Will Benefit:
Manufacturing Engineers
Process Engineers
Quality Engineers
Engineering Managers
Quality Managers
Auditors
Compliance Specialists
Speaker Profile
Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.