Miss.Susanne Manz

Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures.  That requires translating requirements into professionally written SOPs with adequate level of detail on how to do things.  Excellent SOPs need mor ...

Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during regulatory inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections effic ...

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 will learn where non-conforming material can occur ...

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 ...

Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures.This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective.You will learn techniques for creati ...

FDA regulations require medical device companies to have a suitable and effective Quality Management System (QMS).And Corrective and Preventive Action (CAPA) is an important tool to address problems within the QMS as well as product quality.The international s ...

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