FDA Concepts for Medical Device Companies - Regulations, Myths, Challenges, and Best Practices

  • Free
  • Published date: October 26, 2016
    • Baltimore, MD , United States

Overview:
This seminar will show you how to structure and optimize your QMS. It all starts with Management Responsibility and a commitment to quality. We'll discuss the concepts of management responsibility, a culture of quality, and continuous improvement. We'll discuss tools and metrics for understand the state of your QMS and how to identify and prioritize opportunities for improvement. We'll discuss the 4 major Quality System elements that are emphasized by the FDA in their QSIT (Quality Systems Inspection Technique) inspections.
Throughout the seminar, we'll emphasize the regulatory expectations and how you can translate them into your QMS. In each section, we'll cover lessons learned from recalls, 483s, and warning letters. We'll discuss myths and challenges and how you can avoid common problems. And will discuss best practices that you can easily adopt and will set you off on the right foot.
Why should you attend?
An efficient and effective Quality Management System (QMS) is a critical success factor for all Medical Device Companies and is necessary for you to meet the needs of all of your stakeholders. A QMS needs to be effective to ensure your products are safe and effective for your customers. It needs to ensure compliance to the regulations and enable you to successfully demonstrate that compliance to the regulators. But, a QMS system also needs to be efficient to allow you to meet the needs of your business stakeholders and shareholders. This seminar will introduce you to the Quality System Regulations and how to translate them into a QMS that can be both nimble and rigorous in ensuring safe and effective products. You will understand the essential capabilities for managing an excellent Quality System.
Areas Covered in the Session:
• Expectations for Medical Device Quality Management Systems
• Regulations
• Quality Management System Structure and Processes
• Lessons Learned
• Myths
• Challenges
• Best Practices
• Inspection Readiness
Location: Baltimore, MD Date: December 1st & 2nd, 2016 and Time: 9:00 AM to 6:00 PM

Venue: The DoubleTree Baltimore-BWI Airport
Address: 890 Elkridge Landing Road - Linthicum, MD 21090

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)
Until October 15, Early Bird Price: $1,295.00 from October 16 to November 29 Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Quick Contact:
NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link – http://bit.ly/2dKfbL2-Medical-Device
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel

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