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2023 PDA_Training-1988x680

PDA EU00134 Mastering Automated Visual Inspection

Nov 15 - Nov 16, 2023
Berlin, Germany

  • Education
  • Europe

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Program Highlights

Taking place from 15-16 November 2023 in Berlin, PDA Europe offers participants an exciting opportunity to develop and refine their practical skills. Various topics related to visual inspection will be covered by leading industry experts in this training course. Please be informed that one of the trainers will support a few modules remotley but will also be available for you for questions remotely.

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.

Agenda

  • Day 1
  • Day 2
  • Wednesday, 15 November 2023

    9:00
    Welcome & Introduction


    9:30
    Theory 1: Introduction Into Regulatory Requirements of Visual Inspection

    • USP 1, USP 788 and 1788, USP 790 and 1790
    • PhEur e.g. 2.9.20 • JP e.g. 6.06
    • Annex 1
    • Similarities and differences in compendial methods
    • 100% inspection and AQL testing
    • Definitions and practical examples of inherent, intrinsic and extrinsic particles

    10:45
    Coffee Break

    11:15
    Theory 2: Introduction Into 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

    12:15
    Lunch Break

    13:15
    Theory 2: Introduction Into Technical Principles of Automated Inspection Machines (cont.)


    14:15
    Theory 3: Considerations on Primary Containers and Product Properties

    • Vials, Ampoules, Syringes, Blow – Fill - Seal, Viscous liquids, Air bubbles / scratches, Refrigerated product containers

    14:45
    Exercise 1: Developing an URS Considering the Triangle Cost / Quality / Time


    15:45
    Coffee Break

    16:15
    Theory 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

    17:15
    Exercise 1 (cont.): Presentation of the Results of the Sub-Groups and Discussion of the Results


    Q & A
    17:30
    End of Training Course Day 1
  • Thursday, 16 November 2023

    9:00
    Recap of Day 1


    9:15
    Theory 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

    10:15
    Exercise 2: Principle Basic Image Processing Using an Open Source Library


    11:00
    Coffee Break

    11:15
    Exercise 2 (cont.): Presentation of the Results


    12:00
    Theory 6: 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

    13:00
    Lunch Break

    14:00
    Theory 7: 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

    15:00
    Theory 8: Operation and Maintenance of Automated Inspection Systems


    15:30
    Coffee Break

    16:00
    Future Trend of Automated Visual Inspection


    16:30
    End of Training Course

Trainers

Aurélien Genet
Aurélien Genet
GSK Vaccines
Fernand Koert
Fernand Koert
PharmaSolution BV Netherlands

Additional Information

  • Learning Objectives

    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 functions of AVI equipment
    • Define your defect kits and validation strategy
    • Develop your own control strategy around AVI
    • Test normality at a glance, interpret, and communicate the results
    • 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
    • Prerequisites: Basic understanding and practical experience of manual inspection (as conveyed in the PDA course ‘Introduction to Visual Inspection’)

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Berlin, Germany

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Regular Price
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All Participants €1.895

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