Mon Oct 15, 9:00 AM - Tue Oct 16, 6:00 PM

Hilton Garden Inn Salt Lake City Airport

4975 Wiley Post Way, Salt Lake City, Utah, 84116, USA, Salt Lake city, UT 84116

Community: Upper West Side

Description

This seminar will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.

Event Details

Description:
This two-day seminar will cover the essentials of an effective yet efficient Quality management system for medical device companies. An efficient and effective Quality System can be a competitive advantage for companies by leading to improved Quality and compliance as well as optimizing the cost of quality. This seminar will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.
In this webinar, we will discuss:
• Regulatory Expectations
• How to plan, structure, and implement a Quality System
• Common problems and lessons from 483 and Warning Letters
• Red-flags that your QS is not effective
• Six essential capabilities for an effective and efficient QMS
• Risk analysis and management techniques
• Process control and performance monitoring
• Culture, Management Responsibility, and maturity
• Strategies for improvement
• Improvement techniques
Why you should attend:
This seminar will help you understand regulatory requirements and how to translate them into a Quality System that is both effective and efficient. You'll learn how to plan, structure, and implement a Quality System specific for your business needs. We'll explore the capabilities that every medical device company needs to ensure quality products and a compliant Quality System. We'll discuss how to define your current situation and create a quality strategy and plans. Will discuss methods to identify, prioritize, and analyze risks. Then, we will move on to continuous improvement, Six Sigma, and Corrective and Preventive Action to address issues within your Quality System. You'll learn how to effectively communicate and escalate risk as well as monitor performance and progress.
This seminar can help you get your Quality System off to a good start and avoid common problems including MDRs, recalls, 483s, and Warning Letters!
The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with

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