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PDA EU00174 Introduction to Automated Visual Inspection

Sep 07 - Sep 08, 2021
1:00 PM
-
5:00 PM
| W. Europe Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

Visual Inspection mastery is fundamental in parenteral manufacturing in order to guarantee both patient safety and cost-effective supply. The capability of Automated Visual Inspection (AVI) has progressed extensively over the years to the point where, when applied appropriately, it can offer significant advantages over manual and semi-automated inspection processes. This has been made possible thanks to major innovations and technology breakthroughs.

In line with these technological advances, the regulatory requirements for this challenging process have been reinforced. As a consequence, AVI machines today are complex and require multidisciplinary project teams for successful implementation and to manage continuous improvement. This course has been devised to support your AVI program development, by addressing critical parameters, key competencies, and practical approaches to managing the inherent complexity of AVI. After a review of regulatory landscape, key functions of AVI equipment and associated critical parameters will be covered. Then, the participants will look at the interaction between primary packaging component and AVI of the filled drug product. Successful URS development will be covered in order to address not only user needs but also to produce a comprehensive process flow model. Then, the need for an effective Manual Visual Inspection (MVI) baseline process will be overviewed as a prerequisite to AVI. Then, defect kits and validation strategies will be described. AVI has a scope broader than computer vision alone and the overall control strategy for the process will be covered.

Agenda

  • Day 1
  • Day 2
  • Tuesday, 7 September 2021

    13:00

    Welcome & Introduction

    13:15

    Part 1: Introduction to Regulatory Landscape for Visual Inspection

    • Pharmacopeias
    • Findings of recent audits

    13:45

    Part 2: Machine Overview with Videos

    14:00

    Part 3: Introduction to Technical Principles of Automated Inspection Machines

    • Functionality of automated inspection machines
    • Camera systems / light / motion
    • Image processing and database system
    • Interlinkage of parameters: Speed, Rotation speed, Inspection parameters, Detection probability, False reject rate
    • Properties, capabilities and limitations of automated inspection systems
    • Scope of Automated Visual Inspection

    15:00

    Coffee Break

    15:15

    Part 3: Introduction to Technical Principles of Automated Inspection Machines (cont.)

    16:00

    Part 4: Selection and Purchasing of an Automated Inspection System

    • Technical requirements
    • Integration into existing processes, lines/ machines and systems
    • Cost and effort considerations
    • Risk assessment

    16:30

    Q & A

    17:00

    End of Day 1

  • Wednesday, 8 September 2021

    13:00

    Recap of Day 1

    13:15

    Part 5: Transition from Manual Inspection to Automated Inspection

    • Manual inspection as a prerequisite for transition to automated inspection
    • Interpretation of inspection results and validation data
    • Considerations on validation program for automated inspection
    • Performance measurement
    • Maintaining the manual inspection

    14:15

    Part 6: Overview of Computer Vision with Videos

    14:30

    Part 7: Qualification Test Set and Routine Test Set

    • Statistical considerations on number of objects containing defects
    • Particle selection, particle size and size uniformity
    • Labelling of test set objects
    • Supply/purchase of test sets
    • Maintaining and lifecycle of test sets
    • Sampling from rejects
    • Defect master library
    • Types of defects
    • Quality requirements

    15:30

    Coffee Break

    15:45

    Part 8: Visual Inspection Lifecycle and Control Strategy

    • Integration of visual inspection into overall manufacturing process
    • Elements of lifecycle
    • Particle identification/characterization
    • Defect libraries as dynamic database
    • AQL and control charting

    16:15

    Future Trend of Automated Visual Inspection

    16:30

    Q & A

    17:00

    End of Training Course

Trainers

Fernand Koert
Fernand Koert
Dresden GlaxoSmithKline Vaccines
Romain Veillon
Romain Veillon
GSK Vaccines

Learning Objectives

Upon completion of this course, you will be able to

  • Acquire basics about regulatory landscape for AVI
  • Be ready to design your URS
  • Understand key function of AVI equipment
  • Define your defect kits and validation strategy
  • Develop your own control strategy around AVI
  • Have basic knowledge about computer vision

Who Should Attend

This course is designed specifically for those who are involved or interested in moving from manual to automated inspection like

  • Managers, supervisors and all decision makers in the visual inspection area
  • Quality personnel, Project and Qualification engineers
  • Prerequisites: Basic understanding and practical experience of manual inspection (as conveyed in the PDA course ‘Introduction to Visual Inspection’)

Registration Fees

Register Now
Registration Type Price
All Participants €800

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