PDA 417.1 Introduction to Visual Inspection

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This live eLearning training course covers the fundamentals of visual inspection and their application to injectable products. The skills developed through this training course may be applied to both manual human inspection and automated machine inspection.

During this training course, you will learn about patient risks associated with particles in injections; global compendial and regulatory requirements and expectations; inspection techniques for visible particles and container closure defects; critical quality parameters for manual, semi-automated and automated inspection methods; light measurement and control; key elements of a visual inspection program; and inspection lifecycle development.

For more options and/or related training courses, please visit the page(s) below.

PDA Visual Inspection Training Courses

  1. Identify applicable international regulatory and compendial requirements for visual inspection
  2. Apply the critical parameters which must be controlled for reproducible inspection results
  3. Use appropriate statistical tools to assess and compare inspection methods
  4. Develop consistent validation strategies for visual inspection processes and equipment

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Training Course Inquiries
Registration Customer Care

Standard Registration

Member Price

$699

GovernmentMember Only

$699

Health AuthorityMember Only

$699

Early Career ProfessionalMember Only

$699

StudentMember Only

$699

AcademicMember Only

$699

Non-Member

$699

See Qualifying Criteria for Member Types.

Day 1

Why We Inspect (60 min)

  • Why We Inspect
  • Regulatory Requirements – FDA (Recalls/483’s; FD&C Act), EMA (Annex 1)
  • Compendial Requirements (USP, EP, JP)
  • Other Standards

Break (10 min)

Inspection Methods and Technologies (20 min)

  • Manual Inspection
  • Critical Parameters (Lighting, Duration/Speed, Contrast, Agitation)
  • Semi-Automated Inspection
  • Automated Inspection

Break (10 min)

Manual Inspection Exercise (50 min)

  • Basic Inspection Method Instruction
  • Light Measurement
  • Effect of Critical Inspection Parameters on Particulate Inspection (Time, Lighting, Agitation)
  • Inspection Process Data Review (typical class inspection data analysis)

Wrap-Up Discussion / Q&A (30 min)

Day 2

Defect Classification Strategies (30 min)

  • Defect Definitions (Critical, Major, Minor)

Inspector Selection and Qualification (30 min)

  • Vision Screening (Acuity, Correction, Color Blindness)
  • Initial Training
  • Initial Qualification
  • Periodic Requalification

Break (10 min)

Acceptance Sampling (50 min)

  • Sampling Plan Variables (Operational Characteristic Curves, AQL’s and UQL’s, Sample Size)
  • ANSI Z1.4
  • Single and Double Sampling Plans

Inspection Strategies (30 min)

  • Reinspection
  • 2-Stage Inspection
  • Focused Inspection
  • Empty Vial Inspection

Myth Busting / Wrap-Up Discussion / Q&A (30 min)

Agenda is subject to change.

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