Speaker Profile

Susanne
Susanne Manz
Quality and Compliance Expert and Auditor for Medical Devices, Manz Consulting, Inc.,

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.

Upcoming Webinars Recorded Webinars
  • 26
  • April
  • 2021
  • Monday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on Design Controls for Medical Devices

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.

Susanne Manz Susanne Manz | Duration:3 Hours | Price: $299.00 | View Details
  • 29
  • April
  • 2021
  • Thursday
10:00 AM PDT | 01:00 PM EDT

Preparing for an FDA Inspection - What you Need to Know

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 can help you manage inspections efficiently and effectively.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $149.00 | View Details
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $149.00 | View Details
  • 10
  • May
  • 2021
  • Monday
10:00 AM PDT | 01:00 PM EDT

Secrets to Writing Effective SOPs for Medical Device QMS

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.

Susanne Manz Susanne Manz | Duration:60 Minutes | Price: $149.00 | View Details
  • 20
  • May
  • 2021
  • Thursday
09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Susanne Manz Susanne Manz | Duration:3 Hours | Price: $299.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This webinar will help you avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Susanne Manz

Preparing for an FDA Inspection - What you Need to Know

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 can help you manage inspections efficiently and effectively.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $199.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $399.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This webinar will help you avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $549.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $549.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $549.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $549.00 | View Details
Susanne Manz

Preparing for an FDA Inspection - What you Need to Know

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 can help you manage inspections efficiently and effectively.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $399.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $399.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $549.00 | View Details