Miss.Susanne Manz

Area Of Expertise : Quality systems, CAPA
30 Years Of Experience
Training Industry : Life Sciences

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.

 

23 results Found
Live Webinar

QMS Structure and SOP Writing Essentials

Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures.  That requires translating requirements into professionally written SOPs with adequate level of detail on how to do things.  Excellent SOPs need mor ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Oct 28, 2021
Live Webinar

How to manage an FDA Inspection

Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during regulatory inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections effic ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Nov 18, 2021
Live Webinar

Non-conforming Materials and Failure Investigations for Medical Devices

Non-conforming material happens.  And medical device companies must deal it.  This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material.  You will learn where non-conforming material can occur ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Dec 16, 2021
Recorded Webinar

Avoiding Death by CAPA (Corrective and Preventive Action)

We’ll discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We’ll discuss best practices so you can start off on the right foot and always be prepared for an inspection. This webinar will help you ...

  • Intermediate
  • 90 Mins
Recorded Webinar

Spotlight on Complaint Handling and Medical Device Reporting

Complaint management and Medical Device Reporting (MDR) are critical quality systems for you to meet the needs of your 3 key stakeholders – the customer, the regulators, and your business. This webinar will help you to understand the expectations of complaints ...

  • Intermediate
  • 90 Mins
On-Demand Webinar

Metrics and Management Review

Many medical device companies are surprised when they have a recall, a 483, or even a warning letter. To prevent these quality and compliance issues, a company needs to have an efficient and effective Quality Management System (QMS) including good metrics and ...

  • Basic & Advanced
  • 90 Mins
On-Demand Webinar

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 planning, protocol ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Free Webinar

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 techniques for creati ...

  • Intermediate
  • 90 Mins
Free Webinar

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.The international s ...

  • Intermediate
  • 90 Mins
Free Webinar

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 time and resources. ...

  • Intermediate
  • 90 Mins