An efficient and effective Quality Management System (QMS) lies at the heart of a medical device company. Why do so many companies struggle to establish and maintain an efficient and effective QMS? Simple: not only is an efficient and effective QMS necessary to establish quality of the products; it is a regulatory requirement. Regulatory agencies such as the FDA lay heavy and overarching emphasis on a medical device company’ QMS.
At the other end of the spectrum, there are grave consequences to be suffered when a medical device organization fails to put in place an efficient and effective QMS. A weak and faulty QMS can lead all the way from medical device reports to FDA recalls, and from 483s to Warning Letters. And an inefficient QMS results in wasted time, money, and missed opportunities.
And yes, the most important damage an ineffective QMS can result in is a bunch of negative consequences including serious injury, or even death for the user, which can result in lawsuits. A poor QMS also alienates the customer. All these point to the critical need for medical device companies to establish a thoroughly efficient and effective QMS.
Learning on how to build a proper QMS
A valuable two-day seminar from GlobalCompliancePanel a leading provider of professional training for all the areas of regulatory compliance, will show how to establish an efficient and effective QMS that meets regulatory requirements. This is the basis to experiencing all the benefits that such a system brings for the organization.
Susanne Manz, Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc., will be the Director at this two-day seminar. An accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma; Susanne brings an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.
From surviving to thriving
Susanne will instill learning on how to establish an efficient and effective QMS though lectures, exercises, and discussion, which will put the participants on the path to a thorough understanding of the fundamentals of a Quality Management System. The core of this discussion is to help them take their program from surviving to thriving. Creating a sound QMS may help the organization survive FDA scrutiny, but building a thriving QMS can take the organization to a higher plane, which includes achieving their compliance objectives and improving product quality, the result of which is obvious: higher customer satisfaction and increased ROI.
Susanne will take the participants of this seminar from understanding the regulatory requirements to how to create your QMS structure. She will inculcate the method of process thinking that helps them put in an improved strategy. She will also show them the improvement tools and techniques that help them measure their progress.
Susanne will cover the following areas at this seminar:
- Essentials of an effective QMS
- Essentials of an efficient QMS
- Quality is not an Organization
- Key Capabilities
- Maturity Modeling
- Vision, Strategy, and Quality Planning
- Improvement Tools
- Best Practices.
This course has been created to benefit all personnel in a medical device company that are concerned with and related to a QMS, including Quality Systems Specialists, Quality and Compliance Specialists, Auditors, Quality and Compliance Managers and Directors, CAPA Specialists, Project Managers, Supplier Quality Engineers and Auditors, Quality Engineers, Management Representatives, and General Managers.