Process Validation Requirements for FDA's Quality System Regulation
Instructor:
Susanne Manz
Product ID: 706753
- Duration: 90 Min
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 will learn how to avoid these problems and use validation concepts to ensure process stability and control. You will learn the benefits and impacts of validation and how it can benefit your customers and your business. We will cover tools and techniques that can help you successfully validate your processes.
Areas Covered in the Webinar:
- Purpose, scope, and benefits of process validation
- FDA Expectations, Regulations
- Lessons learned and enforcement case studies
- Common problems and solutions
- When to verify and when to validate
- Steps and checklists for validation
- Linkages within your Quality System
- Master Validation Planning
- Best Practices
- Inspection Preparedness
Who Will Benefit:
- Manufacturing Engineers
- Process Engineers
- Quality Engineers
- Engineering Managers
- Quality Managers
- Auditors
- Compliance Specialists
Susanne Manz
President and Principal Consultant, Manz Consulting Inc
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, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
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