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Get an overview of quality systems and understand the what and why founders need to know. 

Developing a business-centric Quality Management System (QMS) involving all the aspects of an organization can make the difference between success and failure.  Quality plays a huge role, especially for those requiring FDA approval or ISO certification. Most company founders do not know their exact position in the regulatory pathway, and the need to build a strong quality culture begins very early. Missing quality processes along the way can mean long delays in FDA approval, especially since companies will be required to go back and update their quality systems. Delays mean a loss of money and could mean the loss of being first to market. This course is for founders. It provides an overview of quality systems and the what and why you, as a founder, need to understand your responsibility regarding the QMS pathway.

Course Details: 

  • Made with founders in mind. It provides an overview of quality systems and the what and why you, as a founder, need to understand your responsibility regarding the QMS pathway.
  • Conducted virtually as a group and with one-on-one sessions with a Subject Matter Expert. The one-on-ones will be scheduled the week after each module so specifics of your company can be discussed.
  • Includes videos from experienced consultants, worksheets, and resources to support your Quality Management System execution.

WEEK ONE- THE FOUNDATIONS

  • The Elements of a Healthy Quality Culture
  • Leading the Quality pathway
    • Leadership’s responsibility for Quality
  • What is a Quality Management System (QMS)
  • Documenting your QMS

WEEK TWO- LEADING THE REGULATORY AND QUALITY MANAGEMENT SYSTEM JOURNEY

  • Understand that Regulatory Requirements are Separate but Related to the Quality system
  • Requirements and Pathways
  • Understand the FDA Requirements by Industry
  • Understand the ISO Requirements by Industry
  • Where/How to Start

WEEK THREE - THE FOUNDATIONS

  • Your Organization’s Core Competencies
  • Gaps and how to implement QMS
  • Working with the FDA
  • Building Organizational Bench Strength – Make or Buy
  • Hiring a QMS Consultant vs. Quality Manager
  • ISO Registrar

Interested in participating? Carly Figman can provide details about pricing, when it's happening, and how to sign up. Reach out today for more info! 

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Carly Figman

Community Engagement Coordinator

carly.figman@ceigateway.com