Susanne Manz
Susanne Manz
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.
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3-Hour Virtual Seminar on Design Control Essentials for Medical Devices
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 customers.... -
Post-Market Surveillance Activities (FDA and EU-MDR) – A Detailed Analysis
Post Market Activities are a GMP regulatory requirement for the medical device industry in both the US and European Union. These activities provide a valuable system for obtaining data and continuous feedback about a medical device that is on... -
Remote Auditing for Medical Device Companies
Internal Audit and Supplier Audits are essential for medical device companies to self-identify and mitigate risks. The COVID-19 pandemic has made this important task even more difficult due to travel restrictions. This webinar will provide insights into how to... -
3-Hour Virtual Seminar on Design Controls for Medical Devices
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 customers.... -
Measurement, Analysis, and Improvement for safe and Effective Medical Devices
This 90 minute Webinar will cover the concepts of measurement, analysis, and improvement to ensure conformity of products, conformity of the management system, and on-going effectiveness. This webinar includes strategies to improve the efficiency of your Quality Management System... -
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... -
3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
Validation is an essential element of the Quality System Regulations and ISO 13485. This course dwells into the processes that need to be validated and what steps are needed to validate the processes. You’ll also learn the essentials of... -
Effective Internal Audit Program
Internal Audit is an essential part of any effective quality system. Most notably, it is an incredibly powerful tool to identify gaps in compliance programs. A well designed internal audit program can be an effective instrument in understanding, communicating,... -
3-Hour Virtual Seminar on Complaint Handling and Medical Device Reporting and Recalls
Despite best efforts, serious quality issues resulting in a recall can occur. Medical Device companies need to be prepared in advance to handle the difficult situation. This 6-hour virtual seminar will prepare you to understand the signals that trigger... -
Secrets to Writing Effective SOPs for QMS
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 creating concise and easy to... -
3-Hour Virtual Seminar on Effective CAPA within a Device Quality System
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... -
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Instituting the right Quality Assurance metrics is significant for numerous reasons. The health of your quality system can be measured using these metrics, which not only helps in changing course but also aids in driving a quality culture, which... -
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.... -
Using Metrics to Monitor and Improve Your Quality System
Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the needs of all their stakeholders: Customers: It is critical to maintain metrics to ensure that your customers are receiving safe and effective... -
Big Data – Tools and Trends for Improving your Quality System
Data, data everywhere. In today’s world, we have access to tremendous amounts of data. Yet, it is difficult to translate this data into useful information. Translating data into meaningful information is a capability that can be a competitive strength... -
Purchasing Controls for Medical Devices
Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations. Additionally, finished Device Manufacturers... -
Sale!
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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.... -
Using Metrics to Monitor and Improve Your Quality System
Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the needs of all their stakeholders: Customers: It is critical to maintain metrics to ensure that your customers are receiving safe and effective... -
Essentials of Post Market Surveillance that you need to know
Post Market Surveillance (PMS) is the practice and system of monitoring the safety awareness training of a medical device after it has been released on the market. It relies on several foundations including unique device identifiers (UDI), electronic... -
Production and Process Controls for Medical Devices
Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. Because Production and Process Controls are so critical they are one of the major subsystems emphasized in... -
Due Diligence – Quality and Compliance Aspects for Medical Devices
Inadequate Due Diligence is not only a missed opportunity but can also lead to disaster years later. Recalls, Warning Letters, Consent Decrees, and significant financial losses can be the result of inadequate Due Diligence. This course will quickly help... -
Sale!
Document Controls for Medical Devices
In the Medical Device industry, companies must “establish and maintain” documents, procedures, and records. This can involve huge numbers of documents. Without a system for control, this can quickly become burdensome and out of control. And when it becomes... -
Making Quality by Design Your Core Strength
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... -
Sale!
Effective Internal Audit Program
“Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well designed audit program can be an effective tool in understanding, communicating, and reducing... -
Product Risk Management Techniques
This webinar will cover Risk Management per ISO 14971 throughout the product lifecycle. Risk Management is an important process to methodically and effectively identifying and mitigating risks in the product design and manufacturing processes. A robust process to identify... -
Writing Effective SOPs for Medical Device Quality Management Systems
The FDA expects Medical Device manufacturers to “establish and maintain procedures”. You will learn what this means and how to comply with expectations. This webinar will help you ensure that your SOPs (Standard Operating Procedures) are complete, concise, and... -
Transforming Your Quality System from Reactive to Proactive – Predictive Compliance
Predictive Compliance will help you identify, investigate, and communicate compliance issues within your organization. This webinar will help you identify and articulate risks in a predictive manner resulting in a more efficient and effective Quality Management System. Almost daily... -
Good Preparation Practices for FDA and Notified Body Audits
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes leading to 483s and even warning letters. This webinar can help you be more professional and polished during an inspection. You will... -
Transforming Your Quality System from Reactive to Proactive
Predictive Compliance will help you identify, investigate, and communicate compliance issues within your organization. This webinar will help you identify and articulate risks in a predictive manner resulting in a more efficient and effective Quality Management System. Almost daily... -
Effective Internal Audit Program
“Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well designed audit program can be an effective tool in understanding, communicating, and reducing... -
Using Metrics to Monitor and Improve Your Quality System
Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the needs of all their stakeholders: Customers: It is critical to maintain metrics to ensure that your customers are receiving safe and effective... -
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... -
Good Preparation Practices for FDA and Notified Body Audits
Description: Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes leading to 483s and even warning letters. This webinar can help you be more professional and polished during an inspection. You... -
Transforming Your Quality System from Reactive to Proactive
Description: Predictive Compliance will help you identify, investigate, and communicate compliance issues within your organization. This webinar will help you identify and articulate risks in a predictive manner resulting in a more efficient and effective Quality Management System. Almost... -
Due Diligence – Quality and Compliance Aspects for Medical Devices
Description: Inadequate Due Diligence is not only a missed opportunity but can also lead to disaster years later. Recalls, Warning Letters, Consent Decrees, and significant financial losses can be the result of inadequate Due Diligence. This course will quickly... -
Using Metrics to Monitor and Improve Your Quality System
Description: Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the needs of all their stakeholders: Customers: It is critical to maintain metrics to ensure that your customers are receiving safe and... -
Using Metrics to Monitor and Improve Your Quality System
Description: Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the needs of all their stakeholders: Customers: It is critical to maintain metrics to ensure that your customers are receiving safe and... -
Good Preparation Practices for FDA and Notified Body Audits
Description: Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes leading to 483s and even warning letters. This webinar can help you be more professional and polished during an inspection. You... -
Transforming Your Quality System from Reactive to Proactive
Description: Predictive Compliance will help you identify, investigate, and communicate compliance issues within your organization. This webinar will help you identify and articulate risks in a predictive manner resulting in a more efficient and effective Quality Management System. Almost... -
Due Diligence – Quality and Compliance Aspects for Medical Devices
Description: Inadequate Due Diligence is not only a missed opportunity but can also lead to disaster years later. Recalls, Warning Letters, Consent Decrees, and significant financial losses can be the result of inadequate Due Diligence. This course will quickly...
