Miss. Susanne Manz

Area Of Expertise : Quality systems, CAPA
30 Years Of Experience

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.

 

26 results Found
Live Webinar

Design for Quality and Compliance

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 ...

  • Intermediate
  • 90 Mins
  • Mar 11, 2020
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 ...

  • Basic & Intermediate & Advanced
  • 90 Mins
On-Demand 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 ...

  • Basic & Advanced
  • 90 Mins
Recorded Webinar

Reduce Compliance and Recordkeeping Burdens

This 90 minute webinar will cover strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies.An effective yet efficient quality system can be a competitive advantage for companies by leading to ...

  • Intermediate
  • 90 Mins
Recorded Webinar

Purchasing Control Essentials for Medical Devices

This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system ...

  • Basic & Intermediate & Advanced
  • 90 Mins
On-Demand Webinar

Top Process Validation Mistakes - And How to Avoid Them

Validation is an important element of the Quality System Regulations and ISO13485.This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate proc ...

  • Intermediate
  • 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 ...

  • Basic & Intermediate & Advanced
  • 90 Mins
On-Demand 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 t ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded 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 ...

  • Basic & Advanced
  • 90 Mins
On-Demand Webinar

Knock, Knock, Who’s There? Preparing for an FDA Inspection

Are you ready for that knock on your door? 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 c ...

  • Intermediate
  • 90 Mins