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Validation Sampling Plans and Setting Acceptance Criteria

This course enables professionals to establish statistically justified sampling plans and acceptance criteria aligned with validation risk profiles and operational requirements. It supports stronger validation decisions where dedicated statistical resources may not be available. This Course is designed for professionals responsible for validation, quality decisions, sampling justification, and process acceptance activities.

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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 : Alan M. Golden
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3590
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Validation activities in pharmaceutical and medical device environments require sampling plans and acceptance criteria supported by statistical rationale rather than informal judgement. Process validation, test method validation, and risk-based acceptance sampling all depend on selecting appropriate sampling approaches that reflect product risk, process variability, and confidence expectations. Organizations without dedicated statistical support often rely on validation and quality personnel to develop these plans internally, increasing the need for practical and technically sound methods.


The course addresses the operational differences between validation sampling and lot acceptance sampling, along with the decisions required before building a sampling plan. It explains variables versus attributes sampling plans, the role of variance in validation decisions, and how process capability measurements such as Cp and CpK influence acceptance criteria. Attention is also given to confidence levels across multiple validation runs and the use of acceptance sampling to support statistically justified validation outcomes.

  • Statistically Grounded Validation Decisions:

    Participants will gain a structured method for developing sampling plans tied to process risk, validation objectives, and measurable variability. The course clarifies how confidence levels, variance evaluation, and process capability affect validation outcomes, helping teams avoid unsupported acceptance criteria that may create inspection concerns or inconsistent qualification results.

  • Practical Application of Sampling and Acceptance Criteria:

    The material provides practical direction for applying variables and attributes sampling plans across process validation and test method validation activities. It also explains how acceptance sampling differs from lot acceptance approaches, allowing validation personnel to build sampling strategies appropriate for regulated pharmaceutical and medical device manufacturing operations.

Key Areas Covered

  • Validation fundamentals and the regulatory purpose of validation activities
  • Statistical principles behind validation sampling and quality determination
  • Differences between validation sampling and lot acceptance sampling
  • Pre-sampling decisions and step-by-step sampling plan development
  • Variables versus attributes sampling plans and their operational use
  • Variance evaluation and the role of statistical measurement in validation decisions
  • Process capability concepts including Cp and CpK for acceptance criteria development
  • Acceptance criteria setting for process validation, test method validation, and risk-based acceptance sampling

Who Must Attend

  • QA/QC Departments
  • Engineering & Production Teams
  • Validation Departments
  • Technical Scientists
  • Validation Statisticians

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

ALAN M. GOLDEN

Alan has more than 30 years of experience in medical device research, quality assurance, validation, and statistical applications within regulated manufacturing environments. During his career at Abbott Laboratories, he worked across diagnostics development, quality systems, process validation, test method validation, CAPA, and risk management. His background includes operational responsibility for quality assurance activities supporting product development and manufacturing. He has delivered international training for over a decade on validation, quality systems, and statistical methods used in regulated industries.

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Your organization deserves the confidence.

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Our students love us ❤️

“Structure helped. Otherwise this topic can get messy quickly.”


Validation Specialist, IT

“Liked the way concepts were broken down. Not too heavy.”


Engineer, Engineering

“Some good points came up during Q&A. That part was useful for us.”

Auditor, Compliance

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