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PDA EU00134 Mastering Automated Visual Inspection
Registration Options
Individual Registration
Group Registration
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
Event Location
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Member Price
€ 2.090Non-Member
€ 2.090
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.
Day 1
Wednesday, 04 December 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
17:30
Q&A
17:45
End of Training Course Day 1
Day 2
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
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
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Aurélien Genet
GSK Vaccines
Aurélien Genet
GSK Vaccines
Aurélien studied Optic & Industrial Vision at Télécom Saint-Etienne (Engineering). During these 3 years, he was in an apprenticeship in a pharmaceutical company at Lilly Fegersheim (France) where Aurélien was a production engineer in Filling & Packaging (qualifying and validating AVI / labeling machines). In 2012, Aurélien was a consultant at Abylsen to work at GSK Vaccines (Belgium). He was a vision engineer in global engineering to create/optimize vision recipes on AVI machines in all GSK production sites. After 1 year, GSK hired Aurélien and he continued this activity for 3 years.
In 2016, Aurélien integrated Manufacturing Science and Technology (MSAT) at GSK Vaccines. He enhanced his knowledge in vision technology (SAVI & MVI) and also in leak testing for specific formats (lyophilized products and tubes). Now he supports manufacturing sites (US, Europe) in implementing new regulations, technology developments, and performance improvements on Visual Inspection, Leak Detection, and Robotics.
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Djonny Rigot
Global Quality Visual Inspection Expert, Sanofi
Djonny Rigot
Sanofi
Djonny Rigot has more than 20 years of experience in the pharmaceutical industry with a strong background in Visual Inspection processes and technologies.
In September 2023, he joined Sanofi as a Global Visual Inspection Expert in GQTO, leading the Global Visual Inspection and CCI program and directly supporting all injectable product sites in the Sanofi network.
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Request InformationPLEASE 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
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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