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Statistical Process Control (SPC) and Control Charts for Laboratory Compliance

Use SPC and control charts to build a proactive laboratory compliance system — monitor performance variables, apply Nelson Rules, and align with 21 CFR Part 211.160 and ISO 17025.

4.8(0 reviews)
1.5 hours
Dr. John C. Fetzer

Instructor

Dr. John C. Fetzer

HPLC Method Development Expert & GLP Compliance Specialist

What You'll Learn

Control charts and their underlying statistical principles
Choosing variables to monitor aligned with 21 CFR Part 211.160 laboratory controls
Maintaining records per ISO/IEC 17025:2017 documentation requirements
Planning adjustments based on control chart signals
Walk-through of control chart implementation and use
Review of relevant statistics including Nelson Rules and Gaussian distributions

About This Event

Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly — handled by adjustments rather than a strict non-compliance event. Control charts are based on the Gaussian distribution of occurrences, with well-defined probabilities and guidelines for acceptable and unacceptable behavior. The most common of these are Nelson Rules, in use for over a century. With a wide selection of variables to monitor, assessing performance can be simple. This webinar is aligned with 21 CFR Part 211.160 requirements for laboratory controls and ISO/IEC 17025:2017 documentation requirements. Code: FDB3466

Curriculum

Control Charts and Their Underlying Statistics
15 min
Choosing Variables to Monitor in the Compliant Laboratory
12 min
Nelson Rules — The Gold Standard for Control Chart Interpretation
12 min

Requirements

  • Lab chemists, managers, technicians, and analysts in regulated industries
  • Applicable to quality, manufacturing, and operations personnel in biotech and pharma

Meet Your Instructor

Dr. John C. Fetzer

Dr. John C. Fetzer

HPLC Method Development Expert & GLP Compliance Specialist

Dr. John C. Fetzer has been doing liquid chromatographic method development for over 35 years. His PhD was in studies of various types of chromatography. He has authored or co-authored over 50 papers on LC separations, has served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry. He supervised the Good Laboratory Practices accreditation of a large research chromatography laboratory and has taught numerous short courses on GLP and ISO 17025 compliance.

PhD Chromatography50+ Published PapersGLP Accreditation ExpertISO 17025 Trainer
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Recording – 1 Viewer

$340.00
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Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

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