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2021Visual-1988x680

2021 PDA Visual Inspection Forum

Apr 14 - Apr 15, 2021
Eastern Standard Time | Online
  • Virtual
  • Conference
  • Online
  • The Americas
Program Highlights

All Forum content will be available on-demand for all registrants after the conference! So even if you can't join live, register today and watch all the talks and Q&As at your convenience after the event!

Frequently Asked Questions

Overview

On behalf of the Program Planning Committee and PDA, we invite you to the 2021 PDA Visual Inspection Forum taking place on 14-15 April 2021. Visual inspection is critical to the manufacture and delivery of high-quality injectable medicines. The Forum provides a platform to present and discuss new developments in the field of VI. This year, we have a special focus on the use of automated visual inspection technology to meet critical inspection needs, especially when rapid scale-up in capacity is required. Discussion will include both the inspection hardware and software, including recent developments with artificial intelligence (AI) applications, along with the validation strategies necessary to deploy this technology.

As always, manual inspection remains an important tool and the most widely used method for visual inspection. It continues to be the pharmacopeial reference method and practical experience with this method will also be addressed. 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. New versions of USP <1790> and EU Annex 1 are expected in 2021, along with guidance from the FDA on visible particles. These new requirements encourage further discussion of the correct understanding and implementation of VI within the pharmaceutical manufacturing supply chain and provide another one of this year‘s hot topics.

We look forward to seeing you virtually for the 2021 PDA Visual Inspection Forum!

Sincerely,

The Co-Chairs

John G. Shabushnig, PhD, Insight Pharma Consulting
Romain Veillon, PharmD, GSK Vaccines

Agenda

  • Day 1
  • Day 2
  • WEDNESDAY, 14 APRIL

    09:00 – 10:00 | Virtual Exhibit Hall Open

    10:10 – 11:10 | Regulatory Overview
    Moderator: John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC

    Regulatory requirements are a major driving force for the development and implementation of appropriate visual inspection procedures. This session will provide an overview on visual inspection requirements; the current regulatory considerations; and the background and essential fundamentals of USP <790> criteria and <1790> guidance.

    Welcome from Program Planning Committee Co-Chairs
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC and Romain Veillon PharmD, Senior Manager, Visual Inspection, GSK Vaccines

    The Changing Visual Inspection Regulatory Environment
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    Current Regulatory Considerations for the Assessment of Visible Particulates in Injectable Pharmaceuticals
    Rukman S. De Silva, PhD,
    Chemist/Product Quality Reviewer, Division of Biotechnology Review and Research IV, OBP, OPQ, CDER, U.S. FDA

    Panel Discussion and Q&A

    11:10 – 11:40 | Virtual Exhibit Hall Open

    11:40 – 12:40 | Concurrent Sessions

    PROCESS TRACK

    11:40 – 12:40 | A1: Particle Investigations
    Moderator: Rick J. Watson, Director, Sterile & Validation CoE, Merck & Co., Inc.

    Executing efficient and comprehensive particle investigations is critical in parenteral manufacturing. This session will provide an overview of particle investigation best practices as well as advanced particle identification techniques.

    Particle Investigation Best Practice
    Robert J. Miller, MS, Director Sterile Injectables Technology, Pfizer Inc

    Identifying the Source of Particulate Matter in Injectables – A Case Study
    Subrata Chakraborty, MS Pharma, Principal Advisor, GxPFONT Consulting Group

    Panel Discussion and Q&A


    TECHNOLOGY TRACK

    11:40 – 12:40 | B1: Automated Inspection Case Studies
    Moderator: Rukman S. DeSilva, PhD, Chemist/Product Quality Reviewer, Division of Biotechnology Review and Research IV, OBP, OPQ, CDER, U.S. FDA

    The evolution of automated inspection assists in achieving increased productivity, accuracy, and consistency. This session highlights the practical aspect of automated inspection process. Multiple case studies related to automated inspection machines will be presented to cover process design and validation.

    Accelerating the Inspection Journey from Feasibility to Vaccine Production: Case Study
    Jeffrey Williams, Manager, Process Engineering, Catalent and Giannina Re, Engineering Project Manager, Stevanato

    Qualification Comparison of a Deep Learning Automated Inspection Machine to Traditional Vision Automated Inspection Machine using KNAPP Methodology
    Ron Lawson BSEE, PMP, Direction of Operations, Prime Results

    Panel Discussion and Q&A

    12:40 – 13:00 | Connect & Network and Tech Talk Video Chats

    13:00 – 14:00 | Concurrent Sessions

    PROCESS TRACK

    13:00 – 14:00 | A2: PDA Task Force Updates
    Moderator: John G. Shabushnig, PhD,
    Principal Consultant, Insight Pharma Consulting, LLC

    PDA has been actively supporting efforts to better understand and ultimately reduce the number of units rejected for visible particles. The papers in this session provide an update on current activities and recently published reports from two groups; one developing and assessing test methods for use with primary packaging components the other surveying current experience and practices with flexible containers.

    Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers
    Rick J. Watson, Director, Sterile & Validation CoE, Merck & Co., Inc.

    PDA Survey: Particulate Matter in Flexible Containers
    Neal A. Zupec, Senior Research Scientist, Baxter Healthcare

    Panel Discussion and Q&A


    TECHNOLOGY TRACK

    13:00 – 14:00 | B2: Automated Inspection
    Moderator: Romain Veillon, PharmD,
    Senior Manager, Visual Inspection, GSK Vaccines

    Recent developments in automated inspection can benefit to the patient with higher defect detection and lower false rejection rate. During AVI machine set-up phase, the opportunities and risks associated with surrogate testing will be explored. Also, the field for small scale AVI equipment will be discussed as Biopharmaceuticals are expanding.

    Placebo vs. Real Product: Opportunities and Challenges during Machine Set-up
    Massimo Frasson, General Manager, BREVETTI C.E.A. S.p.A. and Marion F. Joannes, Meng, Project Manager, DELPHARM ST REMY

    New Requirements of the Inspection and Packaging Process for Small Batch Sized Medicines
    Christian Scherer, Executive Vice President Sales, Körber Pharma Inspection (Seidenader)

    Panel Discussion and Q&A


    14:00 – 14:30 | Connect & Network and Tech Talk Video Chats

  • THURSDAY, 15 APRIL

    09:00 – 10:00 | Virtual Exhibit Hall Open

    10:00 – 11:00 | Concurrent Sessions

    PROCESS TRACK

    10:00 – 11:00 | A3: Combination of AVI and Leak Detection
    Moderator: Derek I. Duncan, PhD, Director Product Line, LIGHTHOUSE Instruments

    Recent emphasis on container closure integrity (CCI) has driven interest in combining leak detection with the automated visual inspection process. This session includes examples of how leak detection technologies have been added to automated visual inspection platforms.

    Automated Inspection of Vials with Lyophilisates
    Matthias Kahl, WILCO AG

    Automated High Voltage Leak Detection Backed by Data
    Wolfram Schindler, Global Product Manager Inspection Technology, Syntegon Technology GmbH

    Panel Discussion and Q&A


    TECHNOLOGY TRACK

    10:00 – 11:00 | B3: Artificial Intelligence (AI) in AVI #1
    Moderator: Robert J. Miller, MS, Director, Sterile Injectables Technology, Pfizer Inc.

    An introduction and recent developments in AI applied to AVI will be discussed. Topics of deep learning pitfalls to avoid and practical considerations for implementation will be covered.

    PDA Task Force Point to Consider AI Applied to VI
    Romain Veillon, PharmD, Senior Manager, Visual Inspection, GSK Vaccines

    Unsupervised Anomaly Detection and Segmentation for Visual Inspection in Highly Optimized Manufacturing Processes
    David Sattlegger, Research Engineer, MVTec Software GmbH

    Panel Discussion and Q&A


    11:00 – 11:30 | Virtual Exhibit Hall Open

    11:30 – 12:30 | Concurrent Sessions

    PROCESS TRACK

    11:30 – 12:30 | A4: Inspection Life Cycle and Process Design
    Moderator: John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    There are many practical considerations when implementing an effective visual inspection program. These talks address getting the most from the process and using it to drive defect reduction through continuous process improvement. They further address practical considerations when establishing process boundaries and appropriate qualification and validation strategies.

    Quality Metrics and Data Integrity for VI, Particulate and Physical Defects in the 21st Century
    Roy T. Cherris,
    Managing Partner, Bridge Associates International & InQuest Science

    Bracketing Strategy Methodology
    Julie E. Mankey, MS, Manager Process Engineer, Pfizer Inc.

    Panel Discussion and Q&A


    TECHNOLOGY TRACK

    11:30 – 12:30 | B4: Artificial Intelligence (AI) in AVI #2 – Defect Classification and Trainings Sets
    Moderator: Linda Willdling, DI Dr,
    Digital & Data Science Program & Portfolio Manager, Takeda Pharmaceuticals International AG

    The power of digitalization is shown everywhere in pharmaceutical industry. Using AI algorithms to enhance the automated visual inspection for difficult to inspect products is a powerful option. The classification of defects and the creation of trainings sets will be discussed and explained further.

    AI Classification Used in Automated Visual Inspection of BFS Container – Aspects of Implementation and Validation
    Florian Krickl, Product Manager,
    VITRONIC

    Practical Guidance for Creating Supervised Learning Training Sets from Manually Labeled Automated Visual Inspection Images for Deep Learning Algorithm Development
    Joseph Straub, Associate Director, Merck & Co., Inc.

    Panel Discussion and Q&A

    12:30 – 13:00 | Connect & Network and Tech Talk Video Chats

    13:00 – 14:15 | Panel Discussion and Forum Highlights
    Moderator: Rick J. Watson, Director, Sterile & Validation CoE, Merck & Co., Inc.

    Highlights from the two days Forum will be shared prior to a panel discussion. The panel discussion will include all of the organizing committee members, representing a wide cross-section of backgrounds and extensive industry experience. The session will allow for expanded discussion of topics presented at the Forum, and the panel will be responding to live questions from attendees.

    Forum Highlights
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC, and Romain Veillon, PharmD, Senior Manager, Visual Inspection, GSK Vaccines

    Panel Discussion
    John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC
    Rukman S. DeSilva, PhD, Chemist/Product Quality Reviewer, Division of Biotechnology Review and Research IV, OBP, OPQ, CDER, U.S. FDA
    Derek I. Duncan, PhD, Director Product Line, LIGHTHOUSE Instruments
    Robert J. Miller, MS, Director, Sterile Injectables Technology, Pfizer Inc.
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
    Romain Veillon, PharmD, Senior Manager, Visual Inspection, GSK Vaccines
    Linda Willdling, DI Dr, Digital & Data Science Program & Portfolio Manager, Takeda Pharmaceuticals International AG

    Closing Remarks from Program Planning Commitee Co-Chairs
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
    Romain Veillon, PharmD, Senior Manager, Visual Inspection, GSK Vaccines

Highlighted Speakers

John D. Ayres
John D. Ayres
Pharma Safety Solutions, LLC
Rukman S.  De Silva
Rukman S. De Silva
U.S. FDA
Derek I. Duncan
Derek I. Duncan
LIGHTHOUSE Instruments
Robert J. Miller
Robert J. Miller
Pfizer Inc.
John G. Shabushnig
John G. Shabushnig
Insight Pharma Consulting, LLC
Romain Veillon
Romain Veillon
GSK Vaccines
Rick J. Watson
Rick J. Watson
Merck & Co., Inc.
Linda Wildling
Linda Wildling
Takeda Pharmaceuticals International AG

Learning Objectives

At the completion of this meeting, participants will be able to:

  • Describe compendial requirements and regulatory trends to ensure their companies are meeting current and anticipated regulatory expectations
  • Identify advances in inspection technology and the necessary steps to successful implementation
  • Identify critical parameters that affect the inspection process
  • Implement an effective and practical visual inspection process
  • Understand and implement a visual inspection lifecycle

Who Should Attend

Departments
Engineering | Manufacturing | Packaging | Process Development | Quality | Technical Services | Validation

Pharmaceutical/Biopharmaceutical Developers
Clinical Supplies | Parenteral Development | Process Development

Inspection Equipment Suppliers
Applications Development | Machine Design | Sales

Registration Fees

Register Now
Early Registration
Registration Type Price by 28 February 2021
Member $798
Non-member $937
Govern./Health Authority/Academic Member $350
Govern./Health Authority/Academic Non-member $400
Student Member $140
Student Non-member $155
Young Professional Member $399
Regular Registration
Registration Type Regular Registration
Price after 31 March 2021
Member $1,117 $1,436
Non-member $1,312 $1,687
Govern./Health Authority/Academic Member $490 $630
Govern./Health Authority/Academic Non-member $560 $720
Student Member $196 $252
Student Non-member $217 $279
Young Professional Member $559 $718

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