2021 PDA Visual Inspection Forum

Name: 2021 PDA Visual Inspection Forum
Start: 2021-04-14
End: 2021-04-15

Apr 14 - Apr 15, 2021

Eastern Standard Time | Online

Virtual
Conference

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Online
The Americas

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Overview
Agenda
Speakers
Additional Information
Registration Fees
Exhibit & Sponsorship
Contact

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

Pharma Safety Solutions, LLC

Rukman S. De Silva

U.S. FDA

Derek I. Duncan

LIGHTHOUSE Instruments

Robert J. Miller

Pfizer Inc.

John G. Shabushnig

Insight Pharma Consulting, LLC

Romain Veillon

GSK Vaccines

Rick J. Watson

Merck & Co., Inc.

Linda Wildling

Takeda Pharmaceuticals International AG

View All

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

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

Inspection Equipment Suppliers
Applications Development | Machine Design | Sales

Registration Fees

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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Contact

Program Inquiries

Molly E. O’Neill, CMP

Vice President

Tel: +1 (301) 656-5900 ext. 132

Exhibition Inquiries

David Hall

Vice President, Sales

Tel: +1 (301) 656-5900 ext. 160

[email protected]

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