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Parenteral Drug Association Connecting People, Science and Regulation ®

Mastering Automated Visual Inspection

Apr 11 - Apr 12, 2018 |
Apr 12, 2018 |
Courtyard by Marriott Berlin City Center | 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.

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

Romain Veillon, Senior Manager Visual Inspection & Leak testing, Global MSAT, GSK Vaccines
Romain Veillon is Senior Manager Visual Inspection & Leak Testing at GSK Vaccines, in Global MSAT Manufacturing Technologies. Currently Romain focuses on Visual Inspection in a global function to support and advise GSK sites in the fields of Quality Integration Lead, Technology Development, Validation Strategy, Capability, Asset Management, Performance Improvement, and Develop Equipment strategy. Furthermore, he is managing a network of vision experts to develop visual Inspection expertise within GSK Vaccines. During the last 18 years he has worked in the area of parenteral manufacturing and has gained experience at Sanofi Pasteur, Eli Lilly and GSK Vaccines in different functions. Romain has developed innovative vision systems with some academic collaboration and is a frequent speaker at PDA conferences.


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.


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 Sébastien 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.

Wednesday, 11 April 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
17:30
End of Day 1

Thursday, 12 April 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

Courtyard by Marriott Berlin City Center
Axel Springer Strasse 55
Berlin 10117
Germany
Tel: +49-30-800 928 0
Hotel Website

The Courtyard Berlin City Center is situated in the heart of the action, placing you near landmarks like Checkpoint Charlie, Potsdamer Platz, Brandenburg Gate and Alexanderplatz. You'll find it easy to relax in your modern, well-appointed hotel lodging; all of the spacious rooms showcase free high-speed Wi-Fi access, luxurious bedding, an ergonomic desk, a mini-fridge and more. Fuel up for your morning in the Mitte district with a hot breakfast buffet at Oléo Pazzo, or end your day with a delicious Mediterranean meal.

We also provide a fully equipped fitness center, a sauna and an on-site coffee house. Host a meeting or social event with us here in Berlin city center to make use of 8,342 square feet of versatile venue space, cutting-edge event technology and innovative planning and catering. Make the Courtyard Berlin City Center your destination of choice for your visit to the Mitte district.

PDA Europe has reserved a limited number of rooms until the 16th February 2018.
Book your room for the PDA Group Rate.

Single Room € 135 per night*
Double Room € 145 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Free Wi-Fi
  • VAT, Taxes and Service Charge will apply

How to Get There

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 6091 1150
Hotel direction: 7.1 miles SE

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 6091 1150
Hotel direction: 11.7 miles NW

This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 2 EUR hourly, 20 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=4154

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