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2023 PDA_Training-1988x680

PDA EU00134 Mastering Automated Visual Inspection

May 25 - May 26, 2023
Leipzig, Germany

  • Education
  • Europe
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Program Highlights

Taking place from 25-26 May 2023 in Leipzig, Germany, 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.

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Agenda

  • Day 1
  • Day 2

  • Thursday, 25 May 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

  • Friday, 26 May 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
Bio
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.
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.

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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Travel

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.

Leipzig Marriott Hotel

Am Hallischen Tor 1
Leipzig, Germany

Make a Reservation
  • Accommodations

    PDA recommends the reservation at the following hotel

    Leipzig Marriott Hotel
    Am Hallischen Tor 1
    04109 Leipzig,
    Germany

    PDA Europe has reserved a limited number of rooms until the 31st March 2023.

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

  • Amenities

    The Hotel is located in the center of Leipzig, around 20 minutes car ride from Leipzig/Halle Airport.

    The hotel does not offer a shuttle bus.

    There are several options for transportation from Leipzig/Halle Airport to the hotel.

How to Get Here

By Air

The international airport of Leipzig is "Leipzig/Halle" located 20 km away from the hotel and conference space.

By Car

Parking is available on site, € 22.00 per day. The parking fee applies only to guests of the Marriott Hotel in Leipzig.

Other Options

Leipzig's main train station is located within 350 meters walking distance.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.895

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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