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Parenteral Drug Association Connecting People, Science and Regulation ®

Mastering Automated Visual Inspection

Oct 25 - Oct 26, 2018 |
Oct 26, 2018 |
Berlin Marriott Hotel | Berlin, Germany
  • Education
  • Europe
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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 continous 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. In day 1, 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 by a practical workshop in order to address not only user needs but also to produce a comprehensive process flow model. In Day 2, 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. ‘Vision Engineering for dummies’ will be explained during a practical workshop using modern vision equipment and genuine examples of production defects

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, 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
  • Test normallity at a glance, interpret, and communicate the results.
  • Have basic knowledge about computer vision

Instructors

Sébastien Koch, Visual Inspection Project and Validation Engineer, Merck Switzerland

Sébastien has over 18 years field experience in visual Inspection. In 2000 he began his career for Eli Lilly as specialist in Vision technology to carry out Automated Visual Inspection Machines (AVIM) qualification, maintenance and continuous improvement. In 2010, as Green Belt Six Sigma ébastien became lean manufacturing engineer to drive operational excellence. In 2012, he took over the lead as Responsible Engineer. In 2016, Sébastien joined Merck in Switzerland to support the Aubonne site development as a driver of change and progress. Responsible of the visual Inspection equipment, he leads the strategic roadmap for long term perspectives, the validation strategy and the permanent competitiveness improvements of the manufacturing processes for quality and cost efficiency.


Fernand Koert, Consultant, Vision Technology, Dresden GlaxoSmithKline Vaccines

Fernand was born in the Hague, Netherlands and started his academic career at the Technical University of Delft to study Electronics. Working in that field, 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 working as a process engineer there after. 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. In 2014, he started with GSK, developing recipes for Seidenader AVI, first in Belgium, and currently for GSK in Dresden, Germany.

Thursday, 25 October 2018

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
17:15

End of Day 1

Friday, 26 October 2018

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

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1495 Euro

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Exterior

Berlin Marriott Hotel
Inge-Beisheim-Platz 1
10785 Berlin
Germany
Tel: +49-30-220000
Hotel Website

Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

PDA Europe has reserved a limited number of rooms until the 12th May 2018.
Book Your Room for the PDA Group Rate

Single Room € 195 per night*
Double Room € 215 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • VAT, Taxes and Service Charge will apply

How to Get There

Berlin-Tegel Airport – TXL
Airport Phone: +49 30 60911150
Hotel direction: 5.6 miles SE

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 60911150
Hotel direction: 12.3 miles NW

This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 3.5 EUR hourly, 30 EUR daily

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4163

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