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2020 Visual Inspection

2020 PDA Europe Virtual Conference - Visual Inspection Forum

Innovations in Automated Visual Inspection

Oct 19 - Oct 20, 2020
Central Europe Standard Time | Online
  • Virtual
  • Conference
  • Europe
Program Highlights

 

The 2020 PDA Europe Visual Inspection Forum will focus on Innovations in Automated Visual Inspection! Join the discussions around new developments in inspection hardware and software, the associated validation strategies as well as the specific regulatory and practical considerations for an effective inspection of the growing number of Cell & Gene Therapy products.

Learn the most recent updates to the European Pharmacopoeia and hear the French Inspectorate ANSM share their main findings regarding visual inspection!

Overview

Dear Colleagues,

On behalf of the Scientific Program Planning Committee and PDA Europe, we would like to invite you to the Visual Inspection Forum to take place on 19-20 October 2020.

This forum will provide a platform to present and discuss new developments in the field of visual inspection. This year we will have a special focus on the use of automated visual inspection technology to meet this critical process need.  Discussion will include both the inspection hardware and software along with the validation strategies necessary to deploy this technology.  

We will also cover the emergence of Deep Learning and key concept associated to this step change like data flow and data integrity. We will also address manual inspection which continues to be the reference method for visual inspection. Also, the holistic VI process will be covered with discussions on control strategies such as AQL and defect trending. Key elements of a basic inspection and sampling process along with special considerations for difficult to inspect parenteral (DIP) products such as lyophilized and biopharmaceutical products, and those in special packing types will be covered. The regulatory and compendial requirements that govern the inspection process will also be discussed. On 20 December 2017, the long-awaited revision to Annex 1 of the EU GMP Guidelines was published. While the currently valid Annex 1 only briefly touches on the important topics of container closure integrity control and visual inspection, this revision contains significantly expanded requirements. The new requirements encourage further discussion of the correct understanding and implementation of visual inspection within the pharmaceutical manufacturing supply chain and provide only one of this year‘s hot topics.

We anticipate a strong agenda of knowledgeable experts in this field along with an exhibition of the latest commercial inspection technology and services.

We look forward to seeing you take part in the 2020 Visual Inspection Forum!

Sincerely,

The Co-Chairs

John Shabushnig, PhD, Insight Pharma Consulting
Romain Veillon,
GSK

Agenda

  • Day 1
  • Day 2
  • Monday, 19 October 2020

    9:00
    Welcome and Introduction

    Falk Klar, PDA Europe
    John Shabushnig, Insight Pharma Consulting, Conference Chair
    Romain Veillon, GSK Vaccines, Conference Chair

    Opening Plenary: Regulatory Updates
    Moderator: Romain Veillon, GSK Vaccines

    Visual Inspection of parenteral drug products is a highly regulated activity by Pharmacopeia’s and Health Agencies. This forum will start with a session dedicated to regulatory updates. First, inspection citations and findings will be presented from the perspective of the French Authorities. Then, last updates from both USP and EDQM pharmacopoeias will be presented.

    09:15
    Visual Inspection: Main Findings from the French Inspectorate (ANSM)

    Gabriel Berbari, ANSM

    09:45
    Update on United States Regulatory and Compendial Expectations for Visual Inspection
    John Shabushnig,
    Insight Pharma Consulting

    10:15
    An Update to the European Pharmacopoeia

    Hanns-Christian Mahler, LONZA

    10:45
    Q&A, Discussion

    11:15 - 11:45
    Coffee Break, Poster Session & Exhibition

    Session 1: Particles & Particle Identification
    Moderator: Markus Lankers,
    MIBIC

    Understanding the source and composition of particulate matter provides the necessary substrate for the development of adequate control strategies and comprehensive risk assessments. This session will discuss the development and use of analytical methods to further characterize and subsequently classify particles in injectables. A comprehensive overview on the PDA's Zero Visible Defects Project shows the complexity of particle sources and approaches for the reduction of the particle load in the manufacturing environment. A novel approach to determine the identity of particles will be also part of this session.

    11:45
    An Update on PDA's Zero Visible Defects Project

    Herve Soukiassian, BD
    Paul Kinsey, GSK

    12:15
    Atomic Force Microscopy – Infrared (AFM-IR) a New Tool for Particle Identification and Characterization?

    Jonas Hoeg Thygesen, Novo Nordisk

    12:45
    Q&A, Discussion

    13:15 - 14:15
    Lunch Break, Poster Session & Exhibition

    Session 2: Inspection of Cell Therapy Products and other Difficult to Inspect Products
    Moderator: Renaud Janssen,
    Datwyler

    Whereas the majority of drug products in the meantime are inspectable with well-established techniques, a number of products remain difficult to inspect. This session illustrates the challenges and progress for two types of such products. In addition, an excursion is made to the visual inspection challenges for single-use assemblies in the drug manufacturing process.

    14:15
    Automatic Inspection of Cell Therapy Products: Challenges and Innovative Methods

    Massimo Frasson, Brevetti C.E.A.

    14:40
    Particulate Detection in the Visual Inspection of Single-Use Assemblies: A Knapp Study

    Klaus Wormuth, Sartorius Stedim

    15:05
    Inspection of Difficult to Inspect Lyophilized and Suspension Products on a Combi Inspection Machine

    Soren Meyer, InnoScan

    15:30
    Q&A, Discussion

    15:45 - 16:15
    Coffee Break, Poster Session & Exhibition

    Session 3: Updates in Automated Visual Inspection
    Moderator: Andrea Sardella,
    Stevanato Group

    Difficult to inspect products can take advantage of latest available technologies and processing concepts to improve the detectability of foreign particulate critical for patient safety. Flexible containers as well as turbid media nowadays have become inspectable thanks to high-resolution sensors and artificial intelligence advanced concepts. It is anyway paramount to develop a proper design of equipment to assess the risks in terms also of occurrence and detectability to not sacrifice productivity and putting in place an effective control strategy to keep under control the risks that even the latest technology cannot mitigate.

    16:15
    Next Generation Toolbox - a Case Study on Automated Visual Inspection of IV-Bags

    Florian Krickl, Vitronic

    16:40
    The Automated Inspection of Opaque Liquid Vaccines

    Gregory Palmer, Leibnitz University Hannover

    17:05
    Risk-based Control Strategies in Automated Visual Inspection

    Bram Keymolen, Eye-Tec

    17:30
    Q&A, Discussion

    18:00
    End of Conference Day 1 & Networking Event



  • Tuesday, 20 October2020

    9:00
    Welcome

    John Shabushnig, Insight Pharma Consulting
    Romain Veillon, GSK Vaccines

    Session 4: Deep Learning & Artificial Intelligence
    Moderator: Romain Veillon,
    GSK Vaccines

    In the years to come, Deep Learning will be a major change for automated visual inspection. This session will cover those changes from the perspectives of regulatory guidance, technology development, validation approaches and new developments in capabilities. After an interactive questionnaire, the new PDA Task Force working on Deep Learning will be showcased. Multiple case studies will be presented to cover process design, validation and false reject reduction. To conclude, a panel discussion will allow rich exchanges on Deep Learning deployment.

    09:05
    Interactive Exercise: Live Mentimeter Questionnaire

    John Shabushnig, Insight Pharma Consulting
    Romain Veillon, GSK Vaccines

    • Expectations of Deep Learning and AI
    • Industry Experience with Deep Learning and AI
    • Challenges of Implementation

    09:15
    Points to Consider for the Use of Deep Learning & AI in Visual Inspection

    John Shabushnig, Insight Pharma Consulting
    Romain Veillon, GSK Vaccines

    09:45
    Deep Learning Applied to Automated Vision Inspection and Key Points for Design and Validation

    Jose Zanardi, Syntegon Technology

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

    Session 5: Deep Learning & Artificial Intelligence, con't
    Moderator: Romain Veillon,
    GSK Vaccines

    10:45
    Non-Invasive Ways of Using Deep Learning/AI to Lower True and False Reject Rates in Automated Inspection Systems

    Connor Kennedy, MSD

    11:10
    Use Case: Implementation of Deep Learning into an Existing Automatic Inspection Machine
    Christian Scherer, Seidenader
    Felix Riehn, Seidenader

    11:35
    Panel Discussion

    12:10 - 13:10
    Lunch Break, Poster Session & Exhibition

    Session 6: Inspection Standards and their Use in Manual Visual Inspection
    Moderator:
    John Shabushnig, Insight Pharma Consulting

    Well-designed and well-maintained reference standard kits for particles and defects are essential to perform successful inspection operations. Attendees will receive an overview of the complex process of developing a reference standard kit with examples given on the most commonly used containers. Also, an approach to a Probability of Detection Study will be shared. It will be discussed how the findings impact the strategy for Visual Inspection Qualification.

    13:00
    The Development of Reference Standard Test Kits

    Swen Maas, Material Analytischer Service

    13:30
    Visual Inspection Qualification Strategy Considering Standard Defects and Reject Zone

    Matteo Rocchi, Eli Lilly & Company
    Valerie Rautureau, Eli Lilly & Company

    14:00
    Q&A, Discussion

    14:30 - 15:00
    Coffee Break, Poster Session & Exhibition

    Closing: Qualification Aspects of VI Technology
    Moderator: John Shabushnig,
    Insight Pharma Consulting

    This session was designed to address practical considerations faced by those who work in the field of visual inspection and stimulate discussion on future directions to improve inspection results. Validation is required and critical to the successful implementation of AVI. False rejects are a concern with all VI methods and impact both cost and yield as well as confidence in the inspection results.

    15:00
    Case Study: Qualification of an Automatic Inspection Line for a Parenteral Product

    Jonny Parsons, Amgen

    15:30
    False Rejection: Just a Matter of Cost or a Possible Impact on Batch Quality?

    Jean-Michel Tasserit, AVI Consulting

    16:00
    Conference Summaries by the Chairs
    John Shabushnig, Insight Pharma Consulting
    Romain Veillon, GSK Vaccines

    16:30
    Closing Remarks & Farewell
    Falk Klar, PDA Europe

Registration Fees

Register Now
Registration Type Price after 23 August
Member €1.795
Non-member €2.095
Govern./Health Authority/Academic €900
Young Professional (Member) €900
Virtual Attendance (All Participants)* €1.395

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