Registration Statistical Tools and Methods for a Quality Systems 
This intensive workshop provides product and process experts a solid understanding of how to use statistical tools and methods to support Design Control and Process Validation. 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).
| PROGRAM OUTLINE | |
Part 1 : Fundamental statistical tools and methods (2.5 days) |
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| Part 2 : Design of Experiments (2.5 days) | |
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Course 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 and Process Validation.
- 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. The workshop has two parts:
- The first half of the workshop will cover fundamental statistical tools and methods.
- The second half of the workshop will focus exclusively on design of experiments.
For the course launch in February, attendees must attend both sessions. For the September workshop and subsequent offerings, attendees can register for either session or attend both sessions at a reduced rate.
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. There are no prerequisites; however, a basic familiarity with MS Excel would be helpful for 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.
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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.
Fees and Registration
Fees include participant notebook of workshop materials and case studies; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
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