This 6 -hour virtual seminar will help you to develop a Quality Management System (QMS) for Medical Device Companies.  A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient.  The regulations require that manufacturers "stablish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured". 

This webinar will cover the basics of how to establish and maintain a suitable QMS including:

• The Basic Requirements
• Management Responsibility
• Quality Audit
• Personnel
• QMS structure
• Quality Policy
• Quality Manual
• Standard Operating Procedures, Work Instructions, Forms, etc.

An efficient, effective QMS sends a message to the FDA and other regulators that your QMS is complete, accurate, and consistently followed.  More importantly, it ensures that your personnel can consistently and accurately meet requirements resulting in correct outcomes and quality work.

Why Should Attend:

An ineffective QMS can lead to serious compliance and quality issues including 483 observations, warning letters, and even consent decrees.  Even worse it can lead to inconsistent or poor product quality including non-conformances, complaints, and even recalls.  And an inefficient QMS leads to confusion, inconsistency, excessive rework, corrective and preventive action, and increased cost of quality.  An inefficient QMS results in wasted time, money, and missed opportunities. It is imperative that medical device companies can effectively and efficiently establish a QMS. 

In this 6-hour virtual seminar, we will explore  the fundamentals of a Quality Management System and how you can take your program from surviving to thriving.  A thriving QMS can help you achieve your compliance objectives and improve product quality, leading to higher customer satisfaction and business results.

Course Objectives:

• Overview of the Regulations
• Essentials of an effective QMS
• Essentials of an efficient QMS
• Lessons learned and common Mistakes
• Maturity modeling
• Improvement tools
• Best practices
• Preparing for an FDA inspection

Course Outline:

•  Regulatory Expectations
•  Lessons Learned from 483s and Warning Letters
•  Common Problems, Mistakes, and Warning Signs
•  How to Structure your QMS
•  Quality Policy and Manual Requirements
•  QMS Structure, Hierarchy, and Documents
•  Roles and Responsibilities
•  Key capabilities
•  Best Practices
•  Vision, Strategy, and Planning

What You Get:

• Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Individual contributors new to a Regulated Industry
• Process Owners or Functional leaders wanting to Improve their Processes
• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Internal Auditors and Managers
• Training Specialists
• CAPA Specialists
• Designated Management Representatives
• Quality/Compliance Managers or Directors for Medical Device companies
• General Managers Wanting to learn about understand Quality System Requirements
• Subject Matter Experts who write Procedures