Courses

Fundamental Statistical Tools and Methods for Quality Systems—Available In-house

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.

Program Outline
 

Day 1
  • Fundamental Concepts & Regulatory Requirements
  • Descriptive Statistics and Process Capability Measures
  • Measure System Analysis (aka, Gage R&R):
    • Variable Measurement Systems
    • Attribute Measurement Systems
 

Day 2
 
  • Capturing the mean, standard deviation, proportion, and process capability (Cpk) through:
    • Confidence Intervals
    • Appropriate Sample Sizes
  • Hypothesis testing for drawing conclusions
 

Day 3
 
  • Acceptance Sampling Plans
  • Statistical Process Control Charts
  • Wrap Up & Regulatory Issues
 

Objectives

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

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.

In-house Only

To bring this program in-house, please contact Linnea Bowman at lbowman@aami.org or call +1 703-253-8283.

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.

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