Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need 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.
You’ll learn the benefits and impacts of validation and how it can benefit your customers and your business. This seminar will cover tools and techniques that can help you successfully validate your processes. Validation can help you to optimize your processes with resulting improvement in predictability, consistency of outputs, and business results.
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 seminar, 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. This seminar will cover tools and techniques that can help you successfully validate your processes. Validation can help you to optimize your processes with resulting improvement in predictability, consistency of outputs, and business results.
Areas Covered in the Session:
- Purpose, scope, and benefits of process validation
- FDA Expectations, Regulations
- Lessons learned and enforcement case studies
- Common problems and easy solutions
- When to verify and when to validate
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Steps and checklists for validation
- Documentation
- Linkages within your Quality System
- Master Validation Planning
- Best Practices
- Inspection Preparedness
Speaker
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.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 Certified Quality Auditor (CQA) 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.
Who Should Attend
- Manufacturing Engineers
- Process Engineers
- Quality Engineers
- Design Engineers
- Engineering Managers
- Quality Managers
- Auditors
- Compliance Specialists
