What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.
It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.
This webinar will help you understand the various interpretations. We will discuss concepts for creating a culture of quality and management excellence with your company.
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.
Areas Covered in the Session:
- 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
- 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
Learning Objectives:
- Warning signals that indicate quality problems within your organization
- Changing your organization form reactive to proactive
- How a culture of quality and compliance can impact your company success
- The risks your company faces from quality and compliance issues
- Creating a culture of quality and compliance at all levels of your organization
Speakers
Susanne Manz,
President and Principal Consultant ,
Manz Consulting, Inc.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.
Who Should Attend
- Quality Systems Specialists
- Quality and Compliance Specialists
- Internal Auditors and Managers
- Training Specialists
- CAPA Specialists
- Management Representatives
- Quality/Compliance Managers or Directors for Medical Device Companies
- Gen
