Overview
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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices including roles as Worldwide Director of Design Quality, Worldwide Director of Product Quality, Executive Business Consultant, and Director of Corporate Compliance. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications in Six Sigma while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification from RAPS and Quality Auditor Certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
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.
Webinar Takeaway
- 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
Faculty Susanne Manz
Consultant | Educator | Author
Baltimore, Maryland Area
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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices including roles as Worldwide Director of Design Quality, Worldwide Director of Product Quality, Executive Business Consultant, and Director of Corporate Compliance. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications in Six Sigma while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification from RAPS and Quality Auditor Certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.