Speaker Profile

Susanne
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.

Upcoming Webinars Recorded Webinars
  • 19
  • December
  • 2022
  • Monday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration:60 Minutes | Price: $150.00 | View Details
  • 21
  • December
  • 2022
  • Wednesday
10:00 AM PST | 01:00 PM EST

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 22
  • December
  • 2022
  • Thursday
08:00 AM PST | 11:00 AM EST

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Susanne Manz Susanne Manz | Duration:4 Hours | Price: $445.00 | View Details
  • 10
  • January
  • 2023
  • Tuesday
09:00 AM PST | 12:00 PM EST

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

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

Susanne Manz Susanne Manz | Duration:3 Hours | Price: $290.00 | View Details
  • 13
  • January
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

6-Hour Virtual Seminar on Audit like the FDA

This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.

Susanne Manz Susanne Manz | Duration:6 Hours | Price: $545.00 | View Details
  • 19
  • January
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 26
  • January
  • 2023
  • Thursday
09:00 AM PST | 12:00 PM EST

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 27
  • January
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Susanne Manz Susanne Manz | Duration:4 Hours | Price: $445.00 | View Details
  • 2
  • February
  • 2023
  • Thursday
09:00 AM PST | 12:00 PM EST

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. This 3-hour seminar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer-focused and ensure product quality and consistency. An effective and efficient design control process results in a predictable product development process with improved quality and compliance results. This seminar can help you create a design control process that is a competitive strength for your company.

Susanne Manz Susanne Manz | Duration:3 Hours | Price: $290.00 | View Details
  • 6
  • February
  • 2023
  • Monday
10:00 AM PST | 01:00 PM EST

4-Hour Virtual Seminar on Improving Your CAPA Program - And preparing for upcoming changes to the Quality System Regulation

The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.

Susanne Manz Susanne Manz | Duration:4 Hours | Price: $445.00 | View Details
  • 9
  • February
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 16
  • February
  • 2023
  • Thursday
10:00 AM PST | 01:00 PM EST

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 21
  • February
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration:60 Minutes | Price: $150.00 | View Details
  • 24
  • February
  • 2023
  • Friday
10:00 AM PST | 01:00 PM EST

6-Hour Virtual Seminar on Purchasing and Supplier Controls

This 6-hour virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management 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 virtual seminar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.

Susanne Manz Susanne Manz | Duration:6 Hours | Price: $545.00 | View Details
  • 28
  • February
  • 2023
  • Tuesday
10:00 AM PST | 01:00 PM EST

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation -IQ,OQ,PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation -IQ,OQ,PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This webinar will help you avoid those struggles and establish 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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Non-Conforming Material and Failure Investigation

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'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Non-Conforming Material and Failure Investigation

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'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Preparing for an FDA Inspection - What you Need to Know

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Preparing for an FDA Inspection - What you Need to Know

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 6-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Susanne Manz

6-Hour Virtual Seminar on Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices

Design Control is considered a critical process by the FDA. Yet, is still a common source of 483 and Warning Letter observations.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 6-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

4-Hour Virtual Seminar on Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

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

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

6-Hour Virtual Seminar on Audit like the FDA

This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

Essentials of Validation - IQ  OQ  PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

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

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

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

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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. This 3-hour seminar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer-focused and ensure product quality and consistency. An effective and efficient design control process results in a predictable product development process with improved quality and compliance results. This seminar can help you create a design control process that is a competitive strength for your company.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

6-Hour Virtual Seminar on Audit like the FDA

This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

4-Hour Virtual Seminar on Improving Your CAPA Program - And preparing for upcoming changes to the Quality System Regulation

The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $495.00 | View Details
Susanne Manz

6-Hour Virtual Seminar on Purchasing and Supplier Controls

This 6-hour virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management 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 virtual seminar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation -IQ,OQ,PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation -IQ,OQ,PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This webinar will help you avoid those struggles and establish 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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Non-Conforming Material and Failure Investigation

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'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Non-Conforming Material and Failure Investigation

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'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Preparing for an FDA Inspection - What you Need to Know

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

Preparing for an FDA Inspection - What you Need to Know

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

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

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Susanne Manz

6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 6-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $945.00 | View Details
Susanne Manz

6-Hour Virtual Seminar on Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices

Design Control is considered a critical process by the FDA. Yet, is still a common source of 483 and Warning Letter observations.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $945.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

6-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 6-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $945.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

4-Hour Virtual Seminar on Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $845.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $845.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $845.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $845.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

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

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

6-Hour Virtual Seminar on Audit like the FDA

This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $945.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $845.00 | View Details
Susanne Manz

Essentials of Validation - IQ  OQ  PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

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

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $845.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $845.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

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

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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. This 3-hour seminar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer-focused and ensure product quality and consistency. An effective and efficient design control process results in a predictable product development process with improved quality and compliance results. This seminar can help you create a design control process that is a competitive strength for your company.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $540.00 | View Details
Susanne Manz

Essentials of Validation - IQ OQ PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

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.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Susanne Manz

6-Hour Virtual Seminar on Audit like the FDA

This 6-hour virtual seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to self-identify areas of non-compliance.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $945.00 | View Details
Susanne Manz

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 4-hour 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.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $845.00 | View Details
Susanne Manz

4-Hour Virtual Seminar on Improving Your CAPA Program - And preparing for upcoming changes to the Quality System Regulation

The FDA has spent years updating the Quality System Regulation (QSR 21 CFR, Part 820) and has finally published draft regulation on February 22, 2022 to harmonize the QSR with ISO 13485:2016. If you’re thinking of improvements to your CAPA process, this is the right time to incorporate ISO13485. This seminar will help you prepare for upcoming changes to the QSR and improve your CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 4 Hours | Price: $845.00 | View Details
Susanne Manz

6-Hour Virtual Seminar on Purchasing and Supplier Controls

This 6-hour virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management 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 virtual seminar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.

Speaker: Susanne Manz | View Anytime | Duration: 6 Hours | Price: $945.00 | View Details