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Visual Inspection Forum

Oct 23 - Oct 24, 2018
Berlin, Germany

On the Path from MVI to AVI - Challenges and Trends

  • Conference
  • Europe

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Program Highlights

The program for the next Visual Inspection Forum in Berlin is out now!

Check the full agenda - now available

Call for Abstracts

Overview

Dear Colleagues,
On behalf of the Scientific Program Planning Committee, we would like to invite you to submit a paper or poster abstract for a presentation at the Visual Inspection Forum held in Berlin / Germany, 23-24 October 2018.

The forum will provide a platform to present and discuss new developments in the field of visual inspection, including a basic understanding of the sampling and inspection process, special aspects of biotech products, practical aspects of manual, semiautomated and automated methods and the regulatory and compendia requirements that govern them.

On 20 December 2017, the long-awaited Annex 1 Revision of the EU GMP Guidelines was finally published. While the currently valid Annex 1 only briefly touches on the important topics of container closure integrity control and visual inspection, this amendment offers a number of innovations. The new requirements encourage further discussion of the correct understanding and implementation in visual inspection and provide only one of this year‘s hot topics to be discussed.

Are you are currently working in Visual Inspection? Do you have insight into the regulatory landscape? Are you developing an innovative concept in research?

We warmly invite you to share your know-how, specific case studies or new data with our distinguished audience.
We look forward to seeing you take part in the Visual Inspection Forum 2018!
Sincerely,

John Shabushnig, PhD,
Insight Pharma Consulting, Chair

Markus Lankers, PhD,
Consultant, Chair

Agenda

  • Tuesday, 23 October 2018

    9:00
    Welcome and Introduction
    Falk Klar, PDA Europe
    Markus Lankers, Consultant, Chair
    John Shabushnig, Insight Pharma Consulting, Chair

    9:15 - 12:30
    Session 1: Regulatory Landscape and Updates
    Moderator: Markus Lankers, Consultant

    9:15
    Proposed Changes to the EU GMP Annex 1 and a Comparison with Corresponding USP Chapters 
    John Shabushnig, 
    Insight Pharma Consulting

    9:45
    Container Closure Integrity Testing –The Impact of the Annex 1 Revision
    Derek Duncan, LIGHTHOUSE

    10:15 – 10:45
    Coffee Break, Poster Session & Exhibition

    10:45
    Visible Particle Requirements in the European Pharmacopeia
    Hanns-Christian Mahler, LONZA

    11:15
    Market Recalls and Inspection Trends for Visual Inspection
    Romain Veillon, GSK

    11:45
    Q&A, Discussion

    12:30 – 13:30
    Lunch Break, Poster Session & Exhibition

    TRANSITION TO PARALLEL TRACKS

    13:30 - 15:30
    Session 2A: Deep Learning and Artificial Intelligence
    Moderator: Heino Prinz, Rommelag

    13:30
    From MVI to Deep Learning
    Romain Veillon, GSK Vaccines

    14:00
    Application of Artificial Intelligence, Machine Learning and Deep Learning to the Pharmaceutical Automatic Inspection Processes
    Massimo Frasson, Brevetti

    14:30
    Improvements on Empty Glass Quality Inspection Using Deep Learning Algorithms
    Massimo Mozzi, SPAMI

    15:00
    Q&A, Discussion

    13:30 - 15:30
    Session 2B: Control Strategies
    Moderator: John Ayres, Pharma Safety Solutions

    13:30
    Statistically Valid Sampling Plans for Automated Inspection Qualification and Routine Operation
    Gabriel Anderson, Novartis

    14:00
    Visual Inspection in the Context of an Overarching Control Strategy
    Elizabeth Zybczynski, Baxter Healthcare

    14:30
    Implementation of Zero Tolerance for Injectable Products
    Montse Domínguez Fernández, Boehringer Ingelheim
    Silvia MarianaBoehringer Ingelheim

    15:00
    Q&A, Discussion

    15:30 – 16:00
    Coffee Break, Poster Session & Exhibition

    16:00 - 18:00
    Session 3: Particle Identification and Supplemental Testing
    Moderator: Renaud Janssen, Datwyler

    16:00
    Analysis of Particulate Matter in Liquid Finished Dosage
    Balazs Havasi, Novartis

    16:30
    Introducing the PDA/PMF Zero Visible Particles Project
    Maurizio Fantozzi, Stevanato Group

    17:00
    Visual Inspection of Single-Use Systems for Biopharmaceutical Processing
    Klaus Wormuth, Sartorius Stedim

    17:30
    Identification of Micro Steel Particles using Energy Dispersive X-ray Spectroscopy coupled with Multivariate Statistics
    Jonas Hoeg Thygesen, Novo Nordisk

    18:00
    End of Conference Day 1

    18:30
    Networking Dinner

    Wednesday, 24 October 2018

    9:00
    Welcome and Introduction
    Markus Lankers, Consultant, Chair
    John Shabushnig, Insight Pharma Consulting, Chair

    9:10 - 12:30
    Session 4: Difficult to Inspect Products
    Moderator: Romain Veillon, GSK

    9:10
    Introducing the new PDA Technical Report TR-79 on Particulate Matter in Difficult to Inspect Parenteral Products
    Roy Cherris, Bridge Associates

    9:40
    An Update on Difficult to Inspect Products, other Physical Characteristics, and Process Related Phenomena Which Equally Influence (Automatic) Inspectability
    Søren C Meyer, InnoScan

    10:10
    Effect of Visual Inspection Parameters on the Inspection Effectiveness for Flexible Containers
    Neal Zupec, Baxter Healthcare

    10:40 – 11:10
    Coffee Break, Poster Session & Exhibition

    11:10
    Spectral Coded Illumination for Reliable Differentiation Between Transparent Particles and Air Bubbles.
    Christian Scherer, Seidenader Maschinenbau

    11:40
    Data Driven Control Strategy for Flexible (IV) Containers
    Frank Dudzik, Baxter Healthcare

    12:20
    Q&A, Discussion

    12:30 – 13:30
    Lunch Break, Poster Session & Exhibition

    13:30 - 15:00
    Session 5: General Inspection Techniques
    Moderator: John Shabushnig, Insight Pharma Consulting

    13:30
    Pulsed X-Ray Particles Inspection for Lyophilisates
    Stephan Bachmeier, Heuft

    14:00
    Advanced Technologies for Automated Visual Inspection of Syringes
    Jose Zanardi, Bosch Packaging Technology

    14:30
    Practical Approach to the Preparation of Defect Standards and Test Sets
    Jean Malthête, GSK Vaccines

    15:00 – 15:30
    Coffee Break, Poster Session & Exhibition

    15:30 - 16:30
    Closing Plenary: Manufacturing and its Clinical Relevance
    Moderator: Andrea Sardella, OMPI

    15:30
    Filtration of IV Drugs
    Markus Lankers, Consultant

    16:00
    Medical Impact of Particles
    John Ayres, Pharma Safety Solutions

    16:20
    Q&A, Discussion

    16:30
    Closing Remarks & Farewell
    Falk Klar, PDA Europe
    Markus Lankers, Consultant,
    John Shabushnig, Insight Pharma Consulting,


Additional Information

  • Call for Abstracts

    Download Call for Papers

    Call for Papers/Abstracts is available now.

    Download

    Abstract Submission

    Call for Papers/Abstracts is available now.

    Submit Abstract
  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • 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:

    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.

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Berlin Mariott Hotel

Inge-Beisheim-Platz 1
Berlin, Germany

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