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.

  •  Thursday, November 15, 2018
  • 10:00 AM PST | 01:00 PM EST,
  • 90 Minutes
  • ¤150.00
Risk Management Techniques for Medical Devices

Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

  •  Monday, November 19, 2018
  • 10:00 AM PST | 01:00 PM EST,
  • 90 Minutes
  • ¤150.00
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. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

  •  Thursday, November 29, 2018
  • 10:00 AM PST | 01:00 PM EST,
  • 90 Minutes
  • ¤150.00
Addressing CAPA within a Device Quality System

This webinar will help you ensure 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.

  •  Tuesday, January 8, 2019
  • 10:00 AM PST | 01:00 PM EST,
  • 90 Minutes
  • ¤150.00
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

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  • Recorded
  • View Anytime
  • ¤190.00
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. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

  • Recorded
  • View Anytime
  • ¤190.00
Addressing CAPA within a Device Quality System

This webinar will help you ensure 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.

  • Recorded
  • View Anytime
  • ¤190.00
Risk Management Techniques for Medical Devices

Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
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 compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

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NetZealous LLC,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

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