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.
Secrets to Writing Effective SOPs
Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures.This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective.You will learn t ...
- Intermediate
- 90 Mins
Six Sigma for Quality and Compliance
FDA regulations require medical device companies to have a suitable and effective Quality Management System (QMS).And Corrective and Preventive Action (CAPA) is an important tool to address problems within the QMS as well as product quality ...
- Intermediate
- 90 Mins
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 ...
- Intermediate
- 90 Mins
Design for Quality and Compliance
Design Control is considered a critical process by the FDA. Yet, is still a common source of 483 and warning letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your ...
- Intermediate
- 90 Mins
Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation ...
- Basic & Intermediate & Advanced
- 90 Mins
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
Reduce Compliance and Recordkeeping Burdens
This 90 minute webinar will cover strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies.An effective yet efficient quality system can be a competitive advantage for companies by leading to ...
- Intermediate
- 90 Mins
Purchasing Control Essentials for Medical Devices
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system ...
- Basic & Intermediate & Advanced
- 90 Mins
Top Process Validation Mistakes - And How to Avoid Them
Validation is an important element of the Quality System Regulations and ISO13485.This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate proc ...
- Intermediate
- 90 Mins
Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation ...
- Basic & Intermediate & Advanced
- 90 Mins