PDA EU00134 Mastering Automated Visual Inspection

04 Dec - 05 Dec 2024
Berlin, Germany

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Program Highlights

Taking place from 04-05 December 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.

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.

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’)

Learning Objectives

Upon completion of this course, attendees 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

Agenda

Discover What's Happening Each Day
Day 1 04 Dec Day 2 05 Dec Workshop Training
Wednesday, 4 December

Wednesday, 04 December 2024

9:00
Welcome & Introduction


9:30
Theory 1: Introduction To 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
  • Findings from audits

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
  • Leak testing principles

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
  • Product impact study

14:45
Exercise 1: Developing Risk Assessment Based on URS


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


17:30
Q&A

17:45
End of Training Course Day 1
Thursday, 5 December

Thursday, 05 December 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
  • Knapp Principle/Fixed criteria

10:15
Exercise 2: Principle Basic Image Processing Using an Open Source Library and Commercial 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 the number of objects containing defects
  • Particle selection, particle size, and size uniformity
  • Labeling 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 the overall manufacturing process
  • Elements of lifecycle
  • Particle identification/characterization
  • Defect libraries as dynamic database
  • AQL sampling principle
  • Control Charting

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

  • Spare part list
  • Predictive maintenance
  • First-line maintenance
  • Calibration

15:30
Coffee Break

16:00
Theory 9: Future Trend of Automated Visual Inspection

  • Moving toward deep learning

16:15
Wrap-up Training Course

  • Evaluation
  • Q&A Discussion

16:30
End of Training Course

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Location and Travel

Venue Details and Accommodations

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA recommends the reservation at the following hotel

INNSide by Meliá Berlin Mitte
Chausseestraße 33
10115 Berlin,
Germany

PDA Europe has reserved a limited number of rooms until 21 October 2024.

Book your room at the PDA Group Rate using the above-mentioned reservation button.

How to Get Here
By Air BER Airport is 8,7 km away from the hotel
Special Deutsche Bahn Train Fares
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Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.

Event Ticket one-way and specific train (subject to availability):

  • 1st class 89,90€ (seat reservation incl.)
  • 2nd class 55,90€

Event Ticket one-way and fully flexible:

  • 1st class 112,90€ (seat reservation incl.)
  • 2nd class 77,90€

Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.

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Registration

Pricing Options

Standard Registration

Member Price

€ 2.090

Non-Member

€ 2.090

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

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 registration-europe@pda.org 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.

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We're currently finalizing our list of sponsors and will share the details shortly.

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