Compliance Boot Camp

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 "Compliance Boot Camp" 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.

In this 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
    Audit for self-awareness
    Risk analysis and management techniques
    CAPA, continuous improvement, and six sigma
    Performance monitoring
    Culture, Management Responsibility, and maturity
    Key Quality System elements and linkages