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Turn a Culture of Quality Into a Competitive Advantage
- FDA and NB expectations for Quality Systems
- Lessons Learned from 483s and warning letters
- How culture can impact quality and compliance risk
- Management commitment and responsibility
- Linkage to quality policy and objectives
- Maturity levels to understand your culture of quality
- Roles and responsibilities
- The case for quality
- Stages of quality and compliance culture
- Tools and techniques for improvement
- Best Practices
Overview of the webinar
A culture of quality is a powerful tool for creating an effective and efficient Quality Management System. A culture of quality is not accidental but can be purposefully nurtured and developed. In this webinar, you’ll learn how to build a culture of quality into your Quality policy, Quality objectives, and into the very fabric of your Quality Management System. A culture of quality decreases compliance and quality risk. And more importantly, it can build trust with your customers and ultimately become a competitive advantage.
Who should attend?
- Quality Engineers
- Compliance 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?
Every organization has stakeholders. Your customers demand safe and effective medical devices. The regulators expect you to follow the regulations for your markets with resulting product quality and compliance. And your business can’t survive without efficient and effective processes to manage scarce resources. This webinar can help you balance and meet all of those expectations. You will learn how to create a culture of quality that can be a competitive advantage.
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.