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Statistical Process Control (SPC) and Control Charts - In Accordance with Latest FDA Expectations

This course enables professionals to apply SPC methods and control chart analysis to support FDA production, process control, validation, and trending expectations while improving process consistency, reducing waste, and strengthening documented quality system decisions. This Course is designed for professionals responsible for regulated manufacturing quality, process monitoring, validation, compliance, and investigations.

REGISTER FOR THE COURSE

US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : John E. Lincoln
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3551
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Statistical Process Control (SPC) plays a central role in maintaining consistent manufacturing performance within FDA-regulated environments. Under 21 CFR 820 and 21 CFR 211, manufacturers are expected to establish and maintain effective process controls supported by appropriate statistical techniques. SPC methods help organizations monitor process behavior, verify product acceptability, justify sampling activities, and identify early indicators of process variation before product quality is affected. Proper implementation also supports periodic quality system analysis and reduces unnecessary rework or scrap.


Regulatory expectations increasingly include documented trend analysis for nonconformances, complaints, and CAPA activities. Effective use of control charts, process capability measurements, GR&R studies, and related statistical tools strengthens production oversight and supports inspection readiness. The course also addresses documentation practices, monitoring of production and laboratory equipment, validation and verification support activities, and statistical justification requirements associated with compliant production and process control systems.

  • Strengthen FDA-Expected Process Monitoring Practices:

    Participants will gain practical understanding of how SPC methods support production and process control requirements under FDA regulations. The course clarifies the use of control charts, process capability analysis, and statistical monitoring techniques to identify process variation early, support product acceptability decisions, and maintain documented evidence expected during inspections and quality system reviews.

  • Improve Statistical Justification and Trending Decisions:

    The course provides operational guidance for applying statistical methods to sampling plans, validations, verifications, and quality trending activities. Participants will better understand how to evaluate nonconformances, complaints, and CAPA data using appropriate statistical approaches, helping reduce compliance exposure associated with weak trend analysis or unsupported quality decisions in regulated manufacturing environments.

Key Areas Covered

  • FDA expectations for statistical techniques under 21 CFR 820 and production/process control requirements under 21 CFR 211
  • SPC fundamentals and application of control charts within regulated manufacturing operations
  • Documentation and recordkeeping requirements supporting SPC activities and quality system analysis
  • Statistical justification of sampling plans, validations, and verification activities
  • Monitoring and control of production, testing, and laboratory equipment using SPC methods
  • Trend analysis approaches for nonconformances, complaints, CAPAs, and NCMRs
  • Use of common statistical tools including GR&R studies, CpK analysis, and related SPC measurements
  • Early detection of process changes to support consistent product quality and reduced rework or scrap

Who Must Attend

  • QA/QC Departments
  • Research and Development Departments
  • Marketing Departments
  • Regulatory Affairs Departments
  • Compliance Professionals
  • Validation Departments

Quality training, expert insights, and answers that matter. Know your Expert

JOHN E. LINCOLN

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC with more than 36 years of experience in FDA-regulated industries, including extensive work in quality systems, CAPA analysis, process validation, regulatory affairs, and FDA compliance remediation. He has supported companies ranging from start-ups to Fortune 100 manufacturers across multiple countries. His background includes implementation of production controls, validation systems, quality investigations, and regulatory response activities directly aligned with SPC and process monitoring practices.

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“Examples were relatable. Not generic. We could map it to what we are currently doing.”

Supervisor, Quality Control

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Senior Manager, Quality Assurance

“Team appreciated the clarity. Especially on a few areas we were unsure about.”

Director, Regulatory Affairs

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