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Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and developing your improvement strategy. We'll discuss tools and techniques for improvement and how to measure your progress. Why you should attend: Many companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. An ineffective QMS can result in serious consequences for your customers leading to dissatisfaction, serious injury, or even death. It is imperative that medical device companies can effectively establish a QMS. And an inefficient QMS results in wasted time, money, and missed opportunities. In this 2-day seminar, we will use lecture, exercises, and discuss to learn 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. Areas Covered in the Session: Essentials of an effective QMS Essentials of an efficient QMS Quality is not an Organization Key Capabilities Maturity Modeling Vision, Strategy, and Quality Planning Improvement Tools Best Practices

Course Audience:
  • Quality Systems Specialists
  • Quality and Compliance Specialists
  • Auditors
  • Quality and Compliance Managers and Directors
  • CAPA Specialists
  • Project Managers
  • Supplier Quality Engineers and Auditors
  • Quality Engineers
  • Management Representatives
  • General Managers

Day 1 Schedule Lecture 1: Regulatory expectations for a QMS Lessons Learned from 483s and warning letters Common problems and simple solutions Lecture 2: QMS Structure Roles and Responsibilities Lecture 3: Management Responsibility, Culture of Quality, Risk Management Lecture 4: Key Capabilities for success Maturity Modeling QMS Evolution Day 2 Schedule Lecture 1: Metrics, internal Audit Cost of Quality Lecture 2: Quality Leadership Lecture 3: Vision and Strategy Quality Planning Lecture 4: Improvement Tools and Techniques CAPA and RCA

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