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2023 PDA_Training-1988x680

PDA EU00134 Mastering Automated Visual Inspection

Apr 11 - Apr 12, 2024
Munich, Germany

  • Education
  • Europe
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Program Highlights

Taking place from 11-12 April 2024, 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.

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.

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Agenda

  • Day 1
  • Day 2

  • Thursday, 11 April 2024

    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

  • Friday, 12 April 2024

    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

Fernand Koert
Fernand Koert
PharmaSolution BV Netherlands
Bio
Fernand Koert
PharmaSolution BV Netherlands

Fernand was born in the Hague, Netherlands and started his academic career at the Technical University of Delft to study Electronics. Due to personal circumstances changed to chemical industry. He completed career stages from shift leader to assistant plant manager. After gaining extensive practical experience, he started studying Process Technology at the Maritime Faculty in Amsterdam, graduating Cum Laude and University of Amsterdam, working as a process engineer thereafter.

In 2000, Fernand became a freelancer helping companies to set up practical training programs for operators. At Teva Pharmaceuticals, he did the same and became head of the packaging department in 2003. In 2005, he returned to technical engineering by assuming responsibility for reshaping and automation of packaging lines. Since 2011, Fernand has been specializing in vision technology, improving and sampling for test kits and validation. SAVI and AVI.

In 2014, he started as a consultant with GSK, developing recipes for Seidenader AVI, first in Belgium, and then for GSK in Dresden, Germany, and worked there as of 2018 as a senior engineer responsible for AVI process improvement and validation. As of September 2022 he restarted his own company and started as a consultant again. First assignment: GSK St-Foy Quebec Canada, working with Seidenader and Brevetti machines.
Romain Veillon
Romain Veillon
GSK Vaccines
Bio
Romain Veillon
GSK Vaccines

Romain Veillon is Director Vision Technology at GSK, in Global MSAT Manufacturing Technologies. As global expert he is leading Visual Inspection performance and expertise network on multiple sites.

He now focuses on Quality Integration Lead, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement and Develop Equipment strategy within network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing in digitalization and innovation management with new AVI-LT asset deployment.

Romain has developed expertise in new AVI equipment qualification and Deep Learning deployment.

Last past 24 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, E Lilly and GSK, in support to production and secondary operations projects for filling and freeze-drying.

He also developed innovative vision systems with some academic collaborations and regular presentation to PDA conferences.

In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain is Interest Group Leader for Visual Inspection in PDA Europe. Since 2019, Romain co-led a taskforce to prepare a point to consider document for AI applied to Visual Inspection.

In 2020 Romain received PDA James P. Agalloco Award for educational training.

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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Munich, Germany

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