[October 17, 2016]

Two-Day Seminar: FDA Concepts for Medical Device Companies - Regulations, Myths, Challenges, and Best Practices (Linthicum, MD, United States - December 1-2, 2016) - Research and Markets

Research and Markets has announced the addition of the "FDA Concepts for Medical Device Companies - Regulations, Myths, Challenges, and Best Practices" conference to their offering.

This webinar 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 understanding 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 (News - Alert) Inspection Technique) inspections.

Throughout the seminar, we'll emphasize the regulatory expectations and how you can translate thm 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.

Agenda

Day 1

Lecture 1:

- Intro to Quality System Regulations

- Management Responsibility

- Culture of Quality

- Metrics for monitoring and improving your Quality System

- Internal Audit is a secret to success

Lecture 2:

- Structuring your Quality Management System

- Document and Change Controls

Lecture 3:

- Writing Excellent SOPs

Lecture 4:

- Corrective and Preventive Action

- Root Cause Analysis

Day 2

Lecture 1:

- Complaints and Medical Device Reporting

Lecture 2:

- Design Controls

- Intro to Risk Management

Lecture 3:

- Production and Process Controls

- Purchasing Controls

Lecture 4:

- Inspection Readiness

For more information about this conference visit http://www.researchandmarkets.com/research/947xbf/fda_concepts_for.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161017006408/en/

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