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    US Individual: $220
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Fundamental Statistical Tools and Methods for Quality Systems

This intensive 3-day workshop provides product and process experts a solid understanding of how to use statistical tools and methods to support Design Control, Process Validation, and Corrective and Preventive Action (CAPA). The content is based on the requirements of the FDA's Quality System regulation and the recommendations of the process validation guidance document developed by the Global Harmonization Task Force (GHTF). Hands-on computer-based training will stress practical application over theory.

Objectives
Upon completion of the workshop, participants will be able to:

• Immediately apply statistical tools and methods to their specific area of responsibility within the medical device industry
• Use statistical tools and methods to support regulatory requirements for Design Control, Process Validation, and Corrective & Preventive Actions (CAPA)
• Draw conclusions through the knowledge gained by examining data
• Apply statistical tools and methods for process validation in accordance with the recommendations made in the Global Harmonization Task Force

Format
This is a computer-based workshop with hands-on exercises to enhance immediate application of statistical methods and tools. It will stress practical application over theory.

Who Should Attend
Instruction is targeted to professionals concerned with the application of valid statistical tools and methods to meet the FDA's Quality System regulation. As such, the content should have great value to industry and FDA individuals and teams involved with: research and development, new product development, process development, manufacturing engineering, operations, quality assurance, and regulatory compliance. Since this is a fast-paced workshop, a basic familiarity with statistical concepts would be helpful. A basic familiarity with MS Excel would be also helpful for the in-class exercises.

Faculty
Course faculty are drawn from an experienced group of quality systems professionals. All course faculty have completed an instructor training program to ensure consistency and quality from session to session. The mix of industry leaders helps ensure a balanced presentation of regulatory requirements and paths to compliance.

Course Materials
Participants will receive pertinent FDA documents, additional references, and a participant’s guide for easy note-taking.  Software and a data disk are part of the course materials that participants can take home and use as guidance long after the course. Due to hands-on computer work, attendees are highly encouraged to bring a laptop to use for class room exercises; those who can’t bring a laptop will be teamed with those who do so that all can share in the computer-based learning experience.

Fee and Registration
Fee includes pertinent FDA documents and additional references, additional references, and PowerPoint presentations; software and a data disk; and continental breakfast, lunch, and refreshments. Click here to go to registration.

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