Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
We’ll discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We’ll discuss best practices so you can start off on the right foot and always be prepared for an inspection. This webinar will help you ...
Complaint management and Medical Device Reporting (MDR) are critical quality systems for you to meet the needs of your 3 key stakeholders – the customer, the regulators, and your business. This webinar will help you to understand the expectations of complaints ...
Many medical device companies are surprised when they have a recall, a 483, or even a warning letter. To prevent these quality and compliance issues, a company needs to have an efficient and effective Quality Management System (QMS) including good metrics and ...
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol ...
This training will help you to write clear, unambiguous and flexible SOPs. You will learn techniques for creating easy to read, clear and concise SOPs that your employees can easily follow. Well-written SOPs ensure that your employees understand and consistently foll ...
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 perf ...
This training will help you to write clear, unambiguous and flexible SOPs. You will learn techniques for creating easy to read, clear and concise SOPs that your employees can easily follow. Well-written SOPs ensure that your employees understand and consistently foll ...
Many medical device companies are surprised when they have quality and compliance issues. To prevent quality and compliance issues, a company needs to have an efficient and effective Quality Management System (QMS) including good metrics and dashboards. Metrics and d ...
This webinar will help you learn the basics of design controls for medical devices. This webinar will focus on the fundamental concept that quality cannot be inspected in… it must be designed in. We’ll cover the regulations and expectations for design control. We’l ...
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 and how to create processes and procedures to implement them. You’ll learn techniques that can ...
