Susanne Manz ,MBA, MBB, RAC, CQA 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. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne 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.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
CAPA is the foundation of an effective Quality Management System.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System.
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Validation is an important element of the Quality System Regulations and ISO13485.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations.
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 time and resources.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Validation is an important element of the Quality System Regulations and ISO13485.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations.
CAPA is the foundation of an effective Quality Management System.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Validation is an important element of the Quality System Regulations and ISO13485.
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 customers.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
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 customers.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Validation is an important element of the Quality System Regulations and ISO13485.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
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 customers.
Validation is an important element of the Quality System Regulations and ISO13485.
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining public safety. Because they are so critical, they are frequently inspected areas by the FDA.
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers.
Validation is an important element of the Quality System Regulations and ISO13485.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Validation is an important element of the Quality System Regulations and ISO13485.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers.
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Validation is an important element of the Quality System Regulations and ISO13485.
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers.
Validation is an important element of the Quality System Regulations and ISO13485.
Validation is an important element of the Quality System Regulations and ISO13485.
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover validation essentials for medical device manufacturers. You’ll learn about what processes need to be validated and what steps you need to take to validate processes.
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Validation is an important element of the Quality System Regulations and ISO13485.
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
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 time and resources.
Validation is an important element of the Quality System Regulations and ISO13485.
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
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 time and resources.
Validation is an important element of the Quality System Regulations and ISO13485.
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Validation is an important element of the Quality System Regulations and ISO13485.
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Design Controls are essential for producing safe and effective medical devices.
This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process
This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process
Design Control is considered a critical process by the FDA.
This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This webinar will help you prepare for upcoming changes to the QSR and improve your CAPA process.
This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.
This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.
This 4-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.
