2023 PDA Visual Inspection Forum

Baltimore, MD
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Program Highlights

Get your VI questions answered by the experts! Throughout the conference, there will be plenty of opportunities to talk to the experts, including at the Ask the Experts interactive panel discussion, Q&A discussions following every session, and networking breaks.

The Program Planning Committee invites you to participate in the 2023 PDA Visual Inspection Forum! Visual inspection (VI) continues to be critical to the manufacture and delivery of high-quality injectable medicines. This forum provides a platform to present and discuss new developments and expectations in the field of VI. This year we have returned to an in-person meeting after the success of the live event in Berlin in 2022.

The regulatory and compendial environment continues to rapidly evolve with new or revised guidance published this year. FDA has published a draft of their Inspection of Injectable Products for Visible Particulates guidance for industry and USP and EMA have finalized updates to USP <1790> and Annex 1, respectively. These new requirements encourage further discussion of the correct understanding and implementation of VI within the pharmaceutical manufacturing supply chain and provide one of this year‘s hot topics.

Automated visual inspection (AVI) provides significant benefits when integrated into the manufacturing process. This is especially true for mass market products such as the recent expansion of COVID vaccine production. Technological advancements, like the use of AI in image analysis and inspection recipe development, can offer significant performance improvements for AVI. Such advancements and other practical case studies on AVI implementation are planned for the agenda in 2023.

As in previous years, manual inspection remains an important means of monitoring and controlling product quality 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. Discussion of the 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 are planned.

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
  • Implement a visual inspection life-cycle
  • Understand and implement a visual inspection life-cycle

Early Bird Pricing

Early Bird Member Price

$1,995

GovernmentMember Only

$795

Health AuthorityMember Only

$795

Early Career ProfessionalMember Only

$1,295

StudentMember Only

$495

AcademicMember Only

$795

Non-Member

$2,395

Standard Pricing

Standard Member Price

$2,495

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$2,895

See Qualifying Criteria for Member Types.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Day 1

MONDAY, 17 APRIL

07:00 – 17:30 | Registration Open

07:30 – 08:30 | Continental Breakfast

08:15 – 10:00 | P1: Regulatory Perspectives
Moderator: Rukman De Silva, PhD, Policy Lead, Division of Internal Policies and Programs(DIPAP), Branch II, OPPQ, OPQ, CDER, U.S. FDA

Visual inspection of parenterals is a critical part of the manufacturing and quality control process, and it’s highly regulated by Health Agencies and Pharmacopeias. This session will cover regulations that govern visual inspection and particle control. Also, the latest regulatory and compendial updates from U.S. FDA, USP and EMA will be presented. 

08:15 | Welcome and Opening Remarks from Forum Co-Chairs 
John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
Romain Veillon, PharmD, Director Vision Technology, GSK Vaccines

08:30 | Particulate Matter Detection and Identification in Biologic Drug Products
Ashwinkumar Bhirde, PhD, Senior Research Scientist,
US FDA 

09:00 | VI Regulatory and Compendial Update: What's New at FDA, USP, and EMA
John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

9:30 | Q&A

10:00 – 10:45 | Refreshment Break and Poster Presentations in the Exhibit Hall

10:45 – 12:15 | P2: Visual Inspection Trends
Moderator: John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

This session provides the first report of updated industry benchmarking conducted through PDA to provide a look at current industry visual inspection practices and results.  This report is followed by a case study in using inspection results to drive continuous process improvement in routine inspections.  Both talks will provide insight into current good practices in VI programs in use today and which may benefit your clinical and commercial operations.  

10:45 | Review of the 2023 PDA Visual Inspection Survey Results
Rick J. Watson, 
Director, Sterile and Validation Center of Excellence, Merck & Co., Inc.

11:15 | How Lifecycle Management Impacts Success of Visual Inspection and Defect Control Implementation
Mariana Araujo Siqueira,
Manager, Quality Operations & Strategy, Baxter Healthcare

11:45 | Q&A

12:15 – 13:30 | Lunch 

13:30 – 15:00 | Concurrent Sessions

A1: Manual Visual Inspection (MVI)
Moderator: 
Elizabeth Zybczynski, Senior Director, cGMP Systems, Baxter Healthcare

This session will touch on the different experiences in the development, execution, and maintenance of human qualification programs.

13:30 | Manual Visual Inspection (MVI) and Inspector Training and Qualification
Emily Beattie, Quality Associate, Quality Operations and Strategy, Baxter Healthcare 

13:50 | Optimized Visual Inspection Training, Qualification and Challenge Standards Data Management
Roy T. Cherris, Senior Advisor and CSO, Bridge Associates Int'l Consulting and InQuest Science
Dan Berdovich, President, Micro Measurement Labs

14:10 | Assessing Visual Inspection Performance Across a Global Network of Manufacturing Sites - How to Execute a Global Threshold Study
Antonio Burazer, Global Head Visual Inspection & Particle LCM, Takeda

14:30 | Q&A

B1: Advances in Automated Inspection (Session 1 of 3)
Moderator: Rick J. Watson,
Director, Sterile and Validation Center of Excellence, Merck & Co., Inc.

Join us for a review of modern techniques that can be used to qualify automated inspection equipment. We will also be looking at novel applications of machine learning as applied to AVI systems.

13:30 | Demonstrating Equivalent or Better Performance: Defending Qualification of AVI
Brady Wern, Lead Process Engineer, Catalent Pharma Solutions

13:50 | State of the Art Visual Inspection Using Machine Learning
Eskild Børsting Sørensen, Data Scientist, Novo Nordisk A/S

14:10 | Strategies for Integrating Deep Learning in Automated Vision Inspection
Conor Kennedy, Specialist Engineering, Merck

14:30 | Q&A

15:00 – 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall

15:45 – 17:15 | Concurrent Sessions

A2: Difficult to Inspect Products and Packages
Moderator: 
Rob J. Miller, MS, Director, Sterile Injectables Technology, Pfizer Inc.

Not all products and presentations are a clear solution in a clear glass vial.  This session will provide options for traditionally difficult-to-inspect presentations and the use of surrogates in process design. 

15:45 | Visual Inspection Approaches for Ophthalmic Solutions Packaged in Opaque and Semi-Transparent Containers
Mary Lee Ciolkowski,
Senior Principal Scientist, Bausch + Lomb

16:05 | Automatic Inspection of Media Fill Test Kit: Feasibility and Advantages
Massimo Frasson, General Manager, Brevetti C.E.A. S.p.A.

16:25 | Surrogate Use for Inspection Qualification: Opportunities and Risks
Sai Teja Neeli, Senior Process Engineer, Catalent Pharma Solutions

16:45 | Q&A

B2: Advances in Automated Inspection (Session 2 of 3)
Moderator: Linda Wildling, PhD,
Head of Digital Innovation Success Management, Takeda

This session is a deep dive into AI use cases, developed to support state-of-the-art AVI systems. We will be discussing how to reduce scrap, improve detection, and what you should take into account in order to be successful. 

15:45 | Presentation of Use Cases Using Deep Learning Models in AVI
Tobias Carlos Tvarnø, Data Scientist, Novo Nordisk A/S

16:05 | Automated Visual Inspection Based on Unsupervised Machine Learning
Brian Turnquist, Chief Technical Officer, Boon Logic

16:25 | Lessons Learned: From a Pilot Study to a Validated Deep Learning Algorithm in Production
Felix Riehn, MSc, Head of Product Management, Körber Pharma Inspection GmbH

16:45 | Q&A

17:15 – 18:30 | Networking Reception in Exhibit Hall

Day 2

TUESDAY, 18 APRIL

07:30 – 17:00 | Registration Open 

07:30 – 08:30 | Continental Breakfast

08:30 – 10:00 | P3: Particle Identification: Who are you and where did you come from?
Moderator: Romain Veillon, PharmD, Director Vision Technology, GSK Vaccines

In this session, we are going to be delving into why particle characterization is key. Once you know about found particles, you can use this information to drive your quality improvement program. Join us to learn how to take this critical first step! 

08:30 | Innovative Prototype for Visible Particle Detection, Characterization, and Chemical Identification in Closed Container
Ilias Amara, F. Hoffmann-La Roche Ltd

09:00 | How to Lose a Particle in 5 Ways
Casey M. Jarvis,
Research Scientist, MVA Scientific Consultants

09:30 | Q&A

10:00 – 10:45 | Refreshment Break and Poster Presentations in Exhibit Hall

10:45 – 12:15 | Concurrent Sessions

A3: Container Closure Integrity Testing (CCIT)
Moderator: Jeffrey Williams, Senior Manager, Process Engineering, Catalent

Leak Detection technologies are often associated with automated visual inspection systems. What are the benefits of such a combination? How can traceability and serialization benefit the patient? How should we respond to Annex1 and USP<1207>?

10:45 | Impact of Primary Container Traceability on Visual Inspection and CCIT
Herve Soukiassian, Assoc. Director Product Development, BD
Christian Kolic, Product Manager Inspection Machines, Körber

11:05 | Next Level Automatic Visual Inspection with CCIT and Serialization
Andrew Pietrangelo,
President, Antares Vision North America 

11:25 | High Voltage Leak Detection: An Invaluable Lab Tool for Assessing Container Closure System Compliance to Annex I and USP1207
Andrea Sardella,
Senior Manager, Stevanato Group

11:45 | Q&A

B3: Advances in Automated Inspection (Session 3 of 3)
Moderator: Felix Riehn, MSc, Head of Product Management, Körber Pharma Inspection GmbH

TMIT and Novo Nordisk will be presenting use cases to show the benefit of AI and its potential to revolutionize visual inspection for the parenteral product. They will also discuss with us the impact of AI on validation kits will be investigated and how qualification routines may change.  

10:45 | Achieving Small False Positive Rate for Automated Visual Inspection via a Dual-Threshold Convolutional Neural Network
Zhengqi Gao, Student, MIT

11:05 | Evolution of Particles and Cosmetic Validation Kits: What Would Be Their Future with the Arrival of Neural Networks?
Massimo Frasson, General Manager, Brevetti C.E.A. S.p.A

11:25 | Using Deep Learning for Visual Inspection
Gitte Bjørg Windfeldt, Head of Product Supply Manufacturing Intelligence Data Science, Novo Nordisk A/S

11:45 | Q&A

12:15 – 13:30 | Networking Lunch with Exhibitors

13:30 – 15:00 | P4: Designing Your Visual Inspection Program
Moderator: Rick J. Watson, Director, Sterile and Validation Center of Excellence, Merck & Co., Inc.

The focus of this session will be on how to design a Visual Inspection Program. Hear our speakers address broad perspectives on how to design and establish the organization and policies that are needed to support visual inspection and particulate control processes.  

13:30 | Optimizing the Visual Inspection Organization
Rob J. Miller, MS, Director, Sterile Injectables Technology, Pfizer Inc.

14:00 | How to Establish a Companywide Effective Visual Inspection Program and Lifecycle Particle Control Strategy
Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG

14:30 | Q&A

15:00 – 15:45 | Refreshment Break and Poster Presentations in the Exhibit Hall

15:45 – 16:45 | P5: Ask the Experts: An Interactive Panel Discussion
Moderators: John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC 
Romain Veillon, PharmD, Director Vision Technology, GSK Vaccines

The panel discussion has been designed to bring together industry experts to discuss and address any questions remaining after the full program of the PDA Visual Inspection Forum. This is your opportunity to ask your remaining questions. Make sure to bring your questions about regulations, inspection methods and technology, and expected inspection results, and get the answers you need! 

16:45 | Closing Remarks from Forum Co-Chairs
J
ohn G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
Romain Veillon, PharmD, Director Vision Technology, GSK Vaccines

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.

Rate: $229 USD for single/double occupancy, plus state and local taxes
Cut-Off Date: Monday, 20 March 2023 (after this date the discounted PDA rate is no longer guaranteed)
Check-In: 16:00
Check-Out: 11:00

Reservations
Online: 
Click on the reservation link above
Phone: +1 (410) 528-1234, make sure to give the PDA Group Code, G-PRDA, to receive the discounted conference rate

Individual Cancellation
48 hours prior to 23:59 local time the day of arrival or 1 night fee. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.
Experience an exceptional stay at the Baltimore Inner Harbor hotel designed for business and vacation travelers. Discover a unique blend of urban luxury and local hospitality with stylish rooms and suites that give you a sense of home and tech savvy enhancements that keep you productive. The convenient location makes it easy to walk to area museums, historic landmarks and attractions like the National Aquarium and Camden Yards. Enjoy what happens when convenience meets charm at Hyatt Regency Baltimore Inner Harbor.
How to Get Here
By Air Baltimore/Washington International Thurgood Marshall Airport (BWI) is approximately 12 miles (20km) from the hotel and all major carriers service this airport. Taxi fares from BWI are approximately $35 one way, not including tip, and will take about 20 minutes.
By Car Hyatt Regency Baltimore Inner Harbor is located at 300 Light Street, Baltimore, MD 21202. Both valet and self-parking are available.