Speaker Profile

Susanne Manz

Quality and Compliance Expert / 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.



Speakers
  •   Monday, February 6, 2023
  •   10:00 AM PST | 01:00 PM EST,
  •   Duration: 4 Hours
  •   $445.00
4-Hour Virtual Seminar on Improving Your CAPA Program - And preparing for upcoming changes to the Quality System Regulation

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.

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Speakers
  •   Friday, February 24, 2023
  •   10:00 AM PST | 01:00 PM EST,
  •   Duration: 6 Hours
  •   $545.00
6-Hour Virtual Seminar on Purchasing and Supplier Controls

This 6-hour virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management enabling you to provide safe and effective products to your customers.

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Speakers
  •   Recorded
  •   View Anytime
  •   Duration: 6 Hours
  •     $595.00
6-Hour Virtual Seminar on Death by CAPA - Does your CAPA Program need a CAPA?

This 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. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.

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Speakers
  •   Recorded
  •   View Anytime
  •   Duration: 6 Hours
  •     $595.00
6-Hour Virtual Seminar on Death by CAPA - Does your CAPA Program need a CAPA?

This 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. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.

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Speakers
  •   Recorded
  •   View Anytime
  •     $190.00
Writing Excellent SOPs

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

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Speakers
  •   Recorded
  •   View Anytime
  •     $190.00
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.Not only do they fail to achieve necessary improvements, they waste precious time and resources.

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