Medical Device Quality Systems, CAPA and European Medical Device regulations

Medical Device Companies must meet the regulatory requirements to “establish and maintain” a quality management system (QMS). This 2-day seminar will cover the essentials of compliance 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 virtual 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. This course will cover the essential for creating a QMS that is both effective and efficient.

This 2-day virtual seminar, 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
• Monitor and measure
• Audit for self-awareness

Who will Benefit:

• Quality System Specialists
• Internal Auditors, Managers, and Directors
• CAPA Specialists
• Compliance Managers or Directors
• Process Owners
• Quality Managers