QA/QC Statistics for Non-Statisticians
Agenda: Day Two
V. Apply Statistical Process Control-
Define Statistical Process Control (SPC)
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Determine how SPC can be applied to and help your process
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Identify the benefits of using SPC
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Trend analysis
Exercise: Review and Critique a Sample SPC Control Chart
VI. Design a Statistically Sound Sampling Plan
- Define different types of sampling
- random
- stratified
- composite
- Create and justify your sampling plan
- Account for sampling and measurement error
- Determine the relationship between sample size, statistical precision, and statistical power
Exercise: Create a Mock Sampling Plan
VII. Comply with FDA Requirements for Process Analytical Technology (PAT)
- Define process analytical technologies and identify related tools
- Identify the role statistics play in the PAT framework
- Comply with the FDA's 2004 PAT draft guidance requirements
VIII. Statistically Analyze Annual Product Review (APR) Data
- Examine statistical techniques relevant to APRs
- Use descriptive statistics to present the data
- Use graphs and plots effectively
- Interpret statistical data to identify trends and deviations
Exercise: Apply Learned Statistical Techniques to Real-World Data
Discussion: Wrap-up Question and Answer Session
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.