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.
Knock, Knock, Who’s There? Preparing for an FDA Inspection
Are you ready for that knock on your door? Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar c ...
- Intermediate
- 90 Mins
- May 30, 2019
Avoiding Death by CAPA – What you need to know
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious ...
- Basic & Advanced
- 90 Mins
- Jun 20, 2019
Six Capabilities Necessary for an Effective and Efficient Quality Management System
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 ...
- Basic & Intermediate
- 60 Mins
Turn a Culture of Quality Into a Competitive Advantage
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 ...
- Basic & Intermediate
- 60 Mins
Metrics for Managing your Quality Management System
Many medical device companies are surprised when they have quality and compliance issues. To prevent quality and compliance issues, a company needs to have an efficient and effective Quality Management System (QMS) including good metrics and dashb ...
- Basic & Intermediate & Advanced
- 90 Mins
Standard Operating Procedures (SOPs) - How to ensure they are complete, clear and accurate!
This training will help you to write clear, unambiguous and flexible SOPs. You will learn techniques for creating easy to read, clear and concise SOPs that your employees can easily follow. Well-written SOPs ensure that your employees understand a ...
- Basic & Intermediate & Advanced
- 90 Mins
Death By CAPA - Does Your CAPA Program Need a CAPA?
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure complian ...
- Basic & Intermediate
- 90 Mins
Excellent Standard Operating Procedures (SOPs): A tool for Quality and Compliance
This training will help you to write clear, unambiguous and flexible SOPs. You will learn techniques for creating easy to read, clear and concise SOPs that your employees can easily follow. Well-written SOPs ensure that your employees understand a ...
- Basic & Intermediate & Advanced
- 90 Mins
Purchasing Controls for Medical Devices
Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations. Additionally, finished D ...
- Basic & Intermediate & Advanced
- 90 Mins
Using Metrics to Monitor and Improve your Quality Management System
Many medical device companies are surprised when they have quality and compliance issues. To prevent quality and compliance issues, a company needs to have an efficient and effective Quality Management System (QMS) including good metrics and dashb ...
- Basic & Intermediate & Advanced
- 90 Mins