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2019 Visual Inspection Week

Mastering Automated Visual Inspection

May 22 - May 23, 2019
Berlin, Germany

Welcome to the 2019 Visual Inspection Week! This new advanced training course has been devised to support the participant to develop his own Automated Visual Inspection program. Prerequisite for the course is basic understanding and practical experience of manual inspection and/or the participation in the PDA Europe course ‘Introduction to Visual Inspection.

  • Education
  • Europe
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Program Highlights

Welcome to the 2019 Visual Inspection Week!

Taking place from 22-24 May 2019 in Berlin, 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 three different training courses. The week will be concluded by the Interest Group Meeting Visual Inspection, providing an additional platform for exchange of experience and expertise with your peers as well as industry professionals in a more personal setting.

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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

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  • Day 1
  • Day 2

  • Wednesday, 22 May 2019

    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, 23 May 2019

    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

  • Thursday, 23 May 2019

    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

Fernand Koert
Fernand Koert
Dresden GlaxoSmithKline Vaccines
Bio
Fernand Koert
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.
Romain Veillon
Romain Veillon
GSK Vaccines
Bio
Romain Veillon
GSK Vaccines

Romain Veillon is Senior Manager Visual Inspection & Leak Testing at GSK Vaccines, in Global MSAT Manufacturing Technologies. As global expert he is leading Visual Inspection performance and expertise network on multiple sites.

He now focuses on Visual Inspection in a global function to support GSK sites for Quality Integration Lead, Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement and Develop Equipment strategy within network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing in machine learning and new concept development.

Last past 18 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, Eli Lilly and GSK Vaccines, in support to production and secondary operations projects for filling and freeze-drying.

He also developed innovative vision systems with some academic collaboration and regular presentation to PDA conferences. 

In 2017, Romain developed a new PDA course Mastering AVI. Since 2018 Romain is Interest Group Leader for Visual Inspection in PDA Europe.

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 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
  • Who Should Attend

    Who Should Attend

    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’)
  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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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.

Courtyard by Marriott Berlin City Center

Axel Springer Strasse 55
Berlin, Germany

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Courtyard by Marriott Berlin City Center
  • Accommodations

    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 08th April 2019.

    Book Your Room for the PDA Group Rate
    Single Room € 135 per night*
    Double Room € 150 per night*

    *Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • usage of Wireless LAN
  • Amenities

How to Get Here

By Air

Nearest Airports:

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 60911150
7.1 mi (11.42 km), 22 min by car
Estimated taxi fare: 28 EUR (one way)
Bus service, fee: 2.7 EUR (one way)
Subway service, fee: 2.7 EUR (one way)
Take the bus X9 and get off at the Zoological Garden. Change to the subway U2 towards Pankow and get off at Spittelmarkt. Cross Seydelstrasse and turn right. The hotel will be on the right.

OR

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 60911150
11.7 mi (18.9 km), 23 min by car
Estimated taxi fare: 40 EUR (one way)
Bus service, fee: 3.3 EUR (one way)
Subway service, fee: 3.3 EUR (one way)
Take the bus SX1 to Südkreuz. Then change to bus 248 to S+U Bahnhof Alexanderplatz and get off at Lindenstrasse/Oranienstrasse. Turn right into Axel-Springer-Strasse, direction Axel-Springer building. The hotel is located at the very end of the street on the left hand side.

By Car

The Marriott Berlin City Center is located at Axel Springer Strasse 55.

Other Options

Bus station: Spittelmarkt, 0.1 miles.

Subway station: Spittelmarkt, 0.1 miles.

Train station: Hauptbahnhof, 3.1 miles.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Contact

Program Inquiries
Exhibition Inquiries

  • Nadjeschda Gomez-Stahl
    Manager, Exhibition & Sponsorship

    gomez@pda.org

Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

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