Susanne Manz
Quality and Compliance Expert / Auditor for Medical Devices
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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. 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 is a CQA (Certified Quality Auditor) 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.

Susanne's new book on Medical Device Quality Management Systems - Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
Upcoming Webinar
Live Sessions Not Found.
Recorded Webinar
Complaint Handling and Medical Device Reporting
Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining public safety. Complaints can be an early warning of issues with your products and customer problems. It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. This webinar will cover the basics of complaint management and medical device reporting.
Recorded Session Get life time access for one participant with download option!

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 writing, and change management. We'll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices
Recorded Session Get life time access for one participant with download option!

Implementing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, they have the ability to change behavior, drive quality culture and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. This course will also discuss the latest draft guidance from the FDA in regards to Quality Metrics.
Recorded Session Get life time access for one participant with download option!

Secrets for Writing Excellent SOPs (Standard Operating Procedures)
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. This webinar will help you structure your QMS and develop accurate, clear, unambiguous SOPs.
Recorded Session Get life time access for one participant with download option!

Quality by Design - Essential Techniques for Medical Devices
Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This webinar will help you understand, develop, and implement design controls processes and tools that are a competitive strength for your company. You will learn how to incorporate design controls into your product development process to help streamline development and ensure quality and compliance.
Recorded Session Get life time access for one participant with download option!

IQ, OQ, PQ in the Verification and Validation Process
Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover what processes needed to be validated and what steps you need to take to validate processes. You'll also learn the essentials of validation planning, protocol writing, and change management.
Recorded Session Get life time access for one participant with download option!

Managing Documents, Records, and Data for FDA Inspections
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. A professional, polished, responsive approach sets a good tone for an inspection. In this webinar, you will learn how to present documents, records, and data about your quality system in the most competent and professional manner.
Recorded Session Get life time access for one participant with download option!

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 processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. We’ll discuss the top mistakes that companies make and how you can avoid them.
Recorded Session Get life time access for one participant with download option!

IQ, OQ, PQ in the Verification and Validation Process
This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.
Recorded Session Get life time access for one participant with download option!

Secrets for Writing Excellent SOPs (Standard Operating Procedures)
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. This webinar will help you structure your QMS and develop accurate, clear, unambiguous SOPs.
Recorded Session Get life time access for one participant with download option!

Effective Purchasing and Supplier Controls for Medical Device Manufacturers
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 for Purchasing Controls! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.
Recorded Session Get life time access for one participant with download option!

Quality by Design
This webinar will help you learn the basics of design controls for medical devices. This webinar will focus on the fundamental concept that quality cannot be inspected in--it must be designed in. We'll cover the regulations and expectations for design control. We'll discuss how design control fits into your Quality Management System. Successful integration can enhance your new product development process.
Recorded Session Get life time access for one participant with download option!

Production and Process Control: Building a Robust System for Medical Device Companies
Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. P&PC is critical to producing safe and effective products for your customers. It is a broad area covering environmental, personnel, contamination, building, equipment, inspection, materials, and more. Because of its criticality, P&PC is one of areas most closely inspected by the FDA. This webinar will help you understand what is necessary for P&PC and how to integrate it seamlessly with the rest of your Quality Management System.
Recorded Session Get life time access for one participant with download option!

FDA's Emerging Signals Guidance: Reporting Medical Device Safety Warnings
On 31 December 2015, the FDA published draft guidance for Industry and FDA Administration. The FDA accepted comments from industry through 29 March 2016. Based on the comments, it is likely that the guidance will change. However, it is clear that the FDA is actively taking steps in asserting its mandate to protect the public health. In this webinar we will discuss how to transform your quality management system from compliance-based to quality-based.
Recorded Session Get life time access for one participant with download option!

Using Metrics to Monitor and Improve your Quality Management System
Metrics and data are a key part of Management Review. Management needs to know how the quality system is performing, where the risks are, and where to invest precious dollars for improvement. This course can help you determine what to measure, how to present information, and how to escalate issues for management review.
Recorded Session Get life time access for one participant with download option!

Secrets for Writing Excellent SOPs (Standard Operating Procedures)
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. This webinar will help you structure your QMS and develop accurate, clear, unambiguous SOPs.
Recorded Session Get life time access for one participant with download option!

Purchasing Controls for Medical Device Companies
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 for Purchasing Controls!
Recorded Session Get life time access for one participant with download option!

Ensuring your Site is Ready for an FDA Inspection
An FDA inspection can be a stressful and challenging experience. This webinar will help you understand the basics of FDA inspections so you can be well prepared. We will discuss how to prepare for an inspection, what to do during an inspection as well as common mistakes to be avoided.
Recorded Session Get life time access for one participant with download option!

Due Diligence of Quality Systems for Medical Device Companies
This webinar will focus on Due Diligence with respect to Quality System requirements. We will discuss what to look for, how to prioritize your activities, and what to report to management. We'll discuss methods for prioritizing findings by risk and creating action plans.
Recorded Session Get life time access for one participant with download option!

Advanced Root Cause Analysis and CAPA Investigations
This webinar will help you improve your root cause analysis leading to real and lasting improvements.<br/><br/> CAPA is the corner stone of an effective Quality System for Medical Device companies. However, it is still the number one cause of 483 and Warning Letter Observations. Without an accurate root cause analysis it is impossible to correct and prevent quality and compliance issues. Many companies struggle with inadequate root cause analysis resulting in on-going quality and compliance problems.
Recorded Session Get life time access for one participant with download option!

eMDR Final Rule Going Live August 14, 2015 - Are you ready?
This webinar will explain about the FDA final rule on Electronic Medical Device Reporting so your company can be ready.
Recorded Session Get life time access for one participant with download option!

Using Metrics to Monitor and Improve Quality Management System
Metrics and data are integral part of Management Review. Management needs to know how the quality system is performing, where the risks are, and where to invest money for improvement. Attending this course will help you to determine what to measure, how to present information, and how to escalate issues for management review.
Recorded Session Get life time access for one participant with download option!

SUBSCRIBE TO NEWSLETTER
Get industry updates and exclusive deals on offers!