PDA EU00174 Introduction to Automated Visual Inspection

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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.

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

Standard Registration

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WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Tuesday, 7 September 2021

Welcome & Introduction

Part 1: Introduction to Regulatory Landscape for Visual Inspection

  • Pharmacopeias
  • Findings of recent audits

Part 2: Machine Overview with Videos

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

Coffee Break

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

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

Q & A

End of Day 1

Day 2

Wednesday, 8 September 2021

Recap of Day 1

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

Part 6: Overview of Computer Vision with Videos

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

Coffee Break

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

Future Trend of Automated Visual Inspection

Q & A

End of Training Course

Agenda is subject to change.

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