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PDA 417.1 Introduction to Visual Inspection

Apr 12 - Apr 13, 2021
1:30 PM
-
4:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

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

Agenda

  • Day 1
  • Day 2
  • 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)

  • 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)

Trainers

Ronald Leversee
Ronald Leversee
Perrigo Company
Matthew Ostrowski
Matthew Ostrowski
Pfizer, Inc.
John G. Shabushnig
John G. Shabushnig
Insight Pharma Consulting, LLC

Learning Objectives

  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

Who Should Attend

This training course is intended for professionals who are involved with visual inspection of parenterals in sterile drug manufacturing.

Departments
  • Quality Control
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Research and Development
  • Validation

Roles
  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager
  • Engineer

Registration Fees

Register Now
Registration Type Price
All Participants $699

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