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Six Capabilities Necessary for an Effective and Efficient Quality Management System
- FDA and NB expectations for Quality Systems
- Lessons Learned from 483s and warning letters
- Six Essential Capabilities
- Maturity modeling of capabilities
- Warning Signs and Red Flags
- Best Practices
Overview of the webinar
The quality management system can be improved by understanding these six essential capabilities.The webinar will highlight warning signs and maturity levels for these six capabilities. Once companies understand their level of maturity, they can create concrete improvement plans.
Who should attend?
- Quality Engineers
- Compliance Specialists
- Auditors
- CAPA Specialists
- Compliance Managers and Directors
- Quality Managers and Directors
- Consultants and Contractors
- Business Leaders wishing to present a professional and compliant organization
- Cross-functional leaders wanting to make sure their organizations are well prepared
- Anyone involved with an FDA or NB inspection
Why should you attend?
The Quality System Regulations for Medical Device are clear on what the expectations are for a medical device manufacturer. But, they don’t provide any input on how to meet the expectations. Many medical device companies struggle to translate the regulations into an effective and efficient quality management system (QMS).This webinar will give you insight on how to do this and make sure that you have the right capabilities to accomplish this.This webinar will explore levels of maturity for these capabilities allowing improved QMS effectiveness and efficiency.
Faculty - Miss.Susanne Manz
Susanne Manz 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. She 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.