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Understanding Medical Device QMS: What they don't teach you at work
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Starts:
Feb 9, 2022 02:00 PM (UTC)
Ends:
Feb 10, 2022 06:00 PM (UTC)
Associated with
Minnesota Section
Biomedical manufacturers and their suppliers rely on an effective quality management system to ensure they produce safe and effective products, and comply with numerous regulatory requirements. Despite the critical importance of the quality management system, many of those working for these types of companies have had little or no formal training. Or, training only focuses on presenting what the regulations and standard state, without really explaining their intent. This class fills that gap by explaining what a quality system is and what its real intent is, the history of the regulations that define the requirements, what those requirements are, and what they really mean. This class will be particularly beneficial for those who typically only get to work within a small part of their company’s quality management system. However, those who have been in the industry for a long time in many roles, may also be surprised by what they hear and learn in this class as the instructor provides a clearer view of the entire system.
Registration:
https://events.eply.com/BMCUnderstandingQMS3364791
Topics to be covered in this
two half-day
workshop:
History of Quality, Standards, Regulations, and the FDA
How did we get here?
Quality System Basic Concepts & Intents
What is Quality and why is it a system?
Management Responsibility
Why does leadership matter to quality?
Resource Management
Are training and competency the same thing?
BTW, there are other resources to manage besides humans
Documents & Records
What’s the difference and how do you produce good ones?
Control of Nonconforming Product
“Product” may not mean what you think it does.
Customer Feedback
Not all feedback is a complaint?
Audits
What are internal audits supposed to be for, and what happens in an external audit?
CAPA
Why is this so important and why do manufacturers keep getting it wrong?
Design Control
What is it and when does it really begin?
Design Transfer
What is it and when does it really begin?
Download to Your Calendar
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