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2019 PDA Visual Inspection Forum

2019 PDA Visual Inspection Forum

Apr 23 - Apr 24, 2019
Washington, DC

Preparing for the Future of Visual Inspection

  • Conference
  • The Americas
Program Highlights

Join your peers and industry experts in Washington, DC for this two-day exploration into the latest scientific breakthroughs and current innovation helping to push the field of visual inspection forward


Visual inspection continues to be an important element of the manufacturing process and the quality assurance of injectable products. Product inspection provides necessary information for lot release, and, coupled with defect identification, contributes to a strategy of continuous process improvement.  Inspection may be accomplished manually or using a variety of automated inspection technologies. A wide range of skills and knowledge is needed to implement a robust inspection program.

PDA’s Visual Inspection Forum was created to provide timely information on this critical processing step. Past meeting topics have included selection and qualification of human inspectors, validation of automated inspection systems, and container integrity and inspection methods. General particle identification and characterization as well as recommendations for difficult to inspect containers and formulations including biopharmaceuticals with inherent protein particles have been addressed.  Finally, regulatory requirements and recent regulatory activity (inspection observations, warning letters, and recalls) and country specific inspection requirements are always topics of interest.

The 2019 PDA Visual Inspection Forum will discuss new developments in the field of visual inspection, including contributions to a basic understanding of the sampling and inspection process, practical aspects of manual and automated methods, and the regulatory and compendial requirements that govern them. A special focus this year will be the inspection life-cycle and the use of inspection results and quality risk management (QRM) concepts to drive continuous process improvement.

The meeting will feature an exhibition where attendees can see the latest in commercial inspection hardware and discuss production needs with key suppliers of inspection systems and services.


  • Day 1
  • Day 2
  • Day 3
  • Monday, April 22

    3:00 p.m. – 6:00 p.m.
    Registration Open

  • Tuesday, April 23

    7:15 a.m. – 6:00 p.m.
    Registration Open

    7:15 a.m. – 8:15 a.m.
    Continental Breakfast

    8:15 a.m. – 8:30 a.m.
    Welcome and Opening Remarks from Conference Co-Chairs
    Markus Lankers, PhD, Consultant, MIBIC GmbH & Co KG and
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    8:30 am. – 10:00 a.m.
    P1: Regulatory Overview and Updates
    Moderator: Markus Lankers, PhD, Consultant, MIBIC GmbH & Co KG

    Regulatory requirements are a driving force for the development and implementation of visual inspection. The session will provide regulatory perspectives on visual inspection issues covering USP <790> and <1790>. Furthermore, an overview and analysis about recalls in different countries during the last years will be summarized and discussed.

    8:30 a.m. – 8:50 a.m.
    Inspection Trends and Market Recall for Visual Inspection
    Romain Veillon, Senior Manager, Vision Inspection & Leak Testing MSAT – Manufacturing Technologies, GSK Vaccines

    8:50 a.m. – 9:10 a.m.
    Regulatory and Compendial Update: What’s New in Visual Inspection Requirements and Guidance
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    9:10 a.m. – 9:30 a.m.
    Regulatory Perspective on Inspection of Injectable Products for Visible Particulates
    Hailin (Sheena) Wang, PhD Chemist, CDER, FDA

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

    9:45 a.m. – 6:45 p.m.
    Exhibit Hall Open

    10:00 a.m. – 10:45 a.m.
    Refreshment Break and Poster Presentations in Exhibit Hall

    Poster Presentations

    The following posters will be presented during refreshment breaks on Tuesday and Wednesday
    1. A Case Study: Investigating the Source of Foreign Particulate Using Multiple Microanalytical Techniques
      Casey M. Brown, Research Scientist, MVA Scientific Consultants
    2. 3D Printing for Enhanced Visual Inspection
      Nicholas K. Coles, Process Engineer, Genentech, Inc.
    3. Direct Atomic Emissions Spectroscopy on Lyo Cake to Significantly Reduce Time for Particle Identification
      Andrew D. Norriss, Principle Engineer, Genentech, Inc.
    4. Failures and Triumphs of an Automated Visual Inspection System
      Neal Zupec, Senior Research Scientist, Baxter Healthcare
    5. To Inspect or No to Inspect – When Should CCI Testing be Part of an Inspection Process?
      Derek I. Duncan, PhD, Drictor Product Line Europe, Lighthouse Instruments
    6. Particle Detection in Printing IV-Bags using Symbol Verification: An New Inspection Method for Difficult to Inspect Products with Printed Flexible Surface
      Florian Krickl,Product Manager, VITRONIC
    7. Determination of the Particulate Matter Contribution to the Pharmaceutical Manufacturing Process from a Widely-used Single-Use-System: Bioprocessing Bags
      David L. Exline, President, Gateway Analytical

    10:45 a.m. – 12:15 p.m.
    P2: Inspection Control Strategies
    Moderator: Rick Watson, Director, Sterile & Validation COE, Merck & Co., Inc.

    As stated in USP <790>, there is an expectation that parenteral manufacturers establish a “complete program for the control and monitoring of particulate matter”. This session covers a wide range control strategies and process design topics that support establishment of a complete and comprehensive inspection program. Presentations in this session will outline key considerations associated with the monitoring of visual inspection reject rates and the establishment of sampling plans. This session will also provide insights into the many product and container related factors that influence particle detection and the design of the container sets used for qualification.

    10:45 a.m. – 11:05 a.m.
    Defect Trending and Defect Limits: Considerations for the Life Cycle Process and Visual Inspection
    Robert J. Miller, Senior Manager Technical Services, Pfizer Inc.

    11:05 a.m. – 11:25 a.m.
    Statistical Sampling Plans to Meet Proposed Annex 1 Revisions Regarding Container Closure Integrity Testing
    Jim Veale, PhD, President, Lighthouse Instruments

    11:25 a.m. – 11:45 a.m.
    A Study of Container and Product Factors that Influence the Probability of Rejection (PR) of Containers with Contaminating Particles
    Gerald W. Budd, President, Phoenix Imaging, Ltd.

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    12:15 p.m. – 1:30 p.m.
    Networking Lunch in Exhibit Hall

    1:30 p.m. – 3:00 p.m.
    P3: Advances in Automated Inspection
    Moderator: Romain Veillon, Senior Manager, Vision Inspection & Leak Testing MSAT – Manufacturing Technologies, GSK Vaccines

    Innovation in Automated Inspection is moving fast forward with emergence of new concepts like Digitalization, Deep Learning and non-visible light inspection. This session will cover 3 cases studies to cover new concept that may reshape automated inspection. First, a case study will focus on enhanced visual inspection for lyophilized vials with non-visible spectrometry. Then, the digitalization concept with image archiving and analysis will be introduced. Finally, advances with Deep-Learning implementation and qualification will be presented.

    1:30 p.m. – 1:50 p.m.
    Going Beyond the Visible to Provide Enhanced Inspection in Lyophilized Products: A Case Study on the Use of Spectroscopy in 100% AVI
    Joanny Salvas, Manager PAT, Pfizer Inc.

    1:50 p.m. – 2:10 p.m.
    Collection, Archival, and Analysis of Images from Automated Vision Inspection: Present Value and Prospective Opportunities
    Joseph A. Straub, Associate Director, Merck & Co., Inc.

    2:10 p.m. – 2:30 p.m.
    Deep Learning Development and Qualification in Automated Vision Inspection Technology for Parenteral Pharmaceutical Drug Products
    Jorge Delgado, Senior Manger Process Development, Amgen

    2:30 p.m. – 3:00 p.m.
    Questions and Answers/Discussion

    3:00 p.m. – 3:45 p.m.
    Refreshment Break and Poster Presentations in Exhibit Hall

    3:45 p.m. – 5:15 p.m.
    P4: Particle Identification, Investigations and Supplemental Testing
    Moderator: John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC

    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 of analytic methods to further characterize and subsequently classify cellulose fibers—a very common particle in injectables; outline adopting a particulate lifecycle management program utilizing USP <1790> assessment and control considerations; and, reviewing the utilization of forensic microscopy to isolate and characterize trace and ultra-trace amounts of particulate matter in sterile ophthalmic solutions and identify its potential source.

    3:45 p.m. – 4:05 p.m.
    Towards an Analytical Method for Identification of Cellulose Fibres
    Jonas Hoeg Thygesen PhD, Area Specialist, Microanalysis Centre, R&D, Novo Nordisk Pharmatech A/S

    4:05 p.m. – 4:25 p.m.
    Ulilization of a Forensic Microscopy (Problem Solving) Approach to the Identification of Subvisible Particles Observed in a Sterile Ophthalmic Solution on Stability
    Mary Lee Ciolkowski, PhD, Senior Principal Scientist, Bausch + Lomb

    4:25 p.m. – 4:45 p.m.
    Adopting a Particulate Matter Lifecycle Approach in Harmony with USP <1790>
    Antonic J. Scatena, Senior Sales Representative, Gateway Analytical

    4:45 p.m. – 5:15 p.m.
    Questions and Answers/Discussion

    5:15 p.m. – 6:45 p.m.
    Networking Reception in Exhibit Hall

  • Wednesday, April 24

    7:30 a.m. – 6:00 p.m.
    Registration Open

    7:30 a.m. – 8:30 a.m.
    Continental Breakfast

    8:30 a.m. – 10:00 a.m.
    P5: Difficult to Inspect Parenterals (DIP)
    Moderator: Roy T. Cherris, Managing Partner, Bridge Associates International & InQuest Science LLC

    Increasing numbers of complex formulations and delivery system presentations that are difficult to inspect have entered the parenteral market. The concept of Difficult to Inspect Parenterals (DIP) describes product container/closure systems and or formations with limited capability for an effective 100% visual inspection. Robust product defect lifecycle management is the key to maintaining product quality with DIPs. The USP<1790> compendial chapter and PDA Technical Report 79 released in 2018 have clarified guidance on how to manage DIP products. This session will present discussions on control strategy approaches to address DIP inspection and supplemental destructive testing.

    8:30 a.m. – 8:50 a.m.
    Keys to Successful Qualification of Automated Inspection Equipment 
    Ron Lawson, Senior Inspection Technology Specialist, Bristol-Myers Squibb

    8:50 a.m. – 9:10 a.m.
    Rise of the Machines: Can Automated Visual Inspection Reduce Human Error in Difficult to Inspect Products?
    Amber H. Fradkin, PhD, Director, Particle Characterization Core Facility, KBI Biopharma, Inc.

    9:10 a.m. – 9:30 a.m.
    Transitioning from Semi-Automated to Automated Inspection: A Case Study for a Difficult to Inspect Product (DIP)
    Aaron Shirkey, Senior Specialist, Engineering, Merck & Co., Inc. and
    Ian T. Jehring,Specialist, Engineering, em>Merck & Co., Inc.

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

    9:45 a.m. – 3:30 p.m.
    Exhibit Hall Open

    10:00 a.m. – 10:45 a.m.
    Refreshment Break and Poster Presentations in Exhibit Hall

    10:45 a.m. – 12:15 p.m.
    P6: Automated and Multi-Stage Inspection Topics 
    Moderator: Robert J. Miller, Senior Manager Technical Services, Pfizer Inc.

    This session will provide some real-world problem solving when moving toward automated or multi-stage inspection processes.  Learn from those who have “been there before” to reduce false rejects in deployed automated systems, ensure that a new multi-stage inspection process is compliant and robust, and selecting the appropriate technology for your specific product.  These case-studies will also highlight contemporary methods for root cause analysis, evaluating inspection effectiveness, and targeted defect detection.

    10:45 a.m. – 11:05 a.m.
    Case Study: Controlling Interactions Between Packaging Components and Injectable Products that Can Lead to False Rejects
    Rick Watson, Director, Sterile & Validation COE, Merck & Co., Inc.

    11:05 a.m. – 11:25 a.m.
    Compliant Approach to Implementation of Multi-Staged Inspection that Combines Automated and Manual Methods Techniques
    Nicola Mauriello, GTO ExM Specialist, MSD International GmbH and
    Andrea Cedrola, Equipment Validation Specialist, Patheon, part of Thermo Fisher Scientific

    11:25 a.m. – 11:45 a.m.
    Use of Automated and Manual Visual Inspection of Container Closure Integrity
    Elizabeth Zybczynski, Director, Production and Process Control, Baxter Healthcare

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    12:15 p.m. – 1:45 p.m.
    Networking Lunch in Exhibit Hall

    1:45 p.m. – 2:45 p.m.
    P7: Commercial Technical Development
    Moderator: John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    Visual inspection systems are constantly evolving to take advantage of new concepts and technology. This session is designed to provide a quick survey of some of the unique technical capabilities in commercially available inspection systems. It should provide a useful benchmark for those considering upgrading existing hardware, assessing how best to meet a new inspection need or preparing for a future transition from manual or semi-automated inspection to automated inspection.

    1:45 p.m. – 1:55 a.m.
    Reliable Differentiation of Air Bubbles From Transparent Particles
    Christain A. Scherer, Head of Sales, Seidenader Maschinenbau GmbH

    1:55 p.m. – 2:05 p.m.
    Particle Detection and Other Challenging Inspections Through a Phased in Machine Learning Approach
    Steven Wardell, Director, Imaging, ATS Automation

    2:05 p.m. – 2:15 p.m.
    Deep Learning in Deep: From Research to Real Application
    Massimo Frasson, General Manager, Brevetti C.E.A. Spa

    2:15 p.m. – 2:25 p.m.
    Automatic Visual Inspection of Lyophilized Products, Characterizes as Difficult to Inspect Products (DIP), with Very Low False Reject
    Søren Christoph Meyer, Mechanical and HW Engineering Manager, InnoScan

    2:25 p.m. – 2:35 p.m.
    Particular Challenges in Automated Visual Inspection of Cartridges for Parenteral Drug Administration
    José M. Zanardi Ocampo, PhD, Senior Manager, Bosch Packaging Technology K.K.

    2:35 p.m. – 2:45 p.m.
    Session Wrap-up

    2:45 p.m. – 3:30 p.m.
    Refreshment Break and Poster Presentations in Exhibit Hall

    3:30 p.m. – 5:00 p.m.
    P8: Clinical Relevance of Particles in Injectable Products
    Moderator: John D. Ayres, MD,  Risk Assessment Clinician, Pharma Safety Solutions, LLC

    Nearing the conclusion of two days discussing the technical and scientific facets of particulate matter control, characterization, and identification this session will explore the question “What does all this mean clinically and what are clinicians saying?” The first speaker will discuss the challenges and risk management strategies involving the potential medical impact of particulates in difficult to inspect products. Next, a review of laboratory and clinical studies will be presented, looking at the potential mitigating impact of bedside in-line filtration in ICU settings. Third, an overview of the potential clinical implications of particles given current manufacturing and inspection capabilities will be presented. The Q&A provides a great opportunity to exploring the interface between capabilities and clinical impact.

    3:30 p.m. – 3:50 p.m.
    Inline Filtration IV Drugs
    Markus Lankers, PhD, Consultant, MIBIC GmbH & Co KG

    3:50 p.m. – 4:10 p.m. 
    A Review of the Potential Clinical Implications of Particulate Matter in Injectables
    R. Douglas Ross, MD, MBA, Senior Director, Pfizer Inc.

    4:10 p.m. – 4:30 p.m.
    Challenges and Risk Management Strategies for Medical Impact of Particulate Matter in Difficult to Inspect Parenterals 
    Nathan Cox, Senior Manager, Quality Engineering, KYMANOX

    4:30 p.m. – 5:00 p.m.
    Questions and Answers/ Discussion

    5:00 p.m. – 5:15 p.m.

    5:15 p.m. – 6:00 p.m.
    P9: Panel Discussion with Moderators
    Moderator: John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    This is an opportunity to highlight, summarize and discuss the key points from both days of the Forum. Each of the session moderators will provide a brief summary of the highlights from their session during the conference.

    5:15 p.m. – 5:45 p.m.
    John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC
    Roy T. Cherris, Managing Partner, Bridge Associates International & InQuest Science LLC
    Markus Lankers, PhD, Consultant, MIBIC GmbH & Co KG
    Robert J. Miller, Senior Manager Technical Services, Pfizer Inc.
    Romain Veillon, Senior Manager, Vision Inspection & Leak Testing MSAT – Manufacturing Technologies, GSK Vaccines
    Rick Watson, Director, Sterile & Validation COE, Merck & Co., Inc.

    5:45 p.m.
    Closing Remarks and Adjournment

Highlighted Speakers

Jorge Delgado
Jorge Delgado
Amber H. Fradkin
Amber H. Fradkin
KBI Biopharma, Inc.
Ian T. Jehring
Ian T. Jehring
Merck & Co., Inc.
Ron Lawson
Ron Lawson
Prime Results
Joanny Salvas
Joanny Salvas
Pfizer Inc.
Aaron J. Shirkey
Aaron J. Shirkey
Merck & Co., Inc.
Joseph A. Straub
Joseph A. Straub
Merck & Co., Inc.
Hailin (Sheena) Wang
Hailin (Sheena) Wang

Additional Information

  • Learning Objectives

    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
    • Apply Quality Risk Management concepts to visual inspection
    • Identify advances in particulate inspection methods and equipment
    • Identify critical parameters that affect the inspection process
    • Implement a visual inspection life-cycle
    • Implement an effective and practical visual inspection process
  • Who Should Attend

    Who Should Attend

    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

  • 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:

    ACPE # 0116-0000-19-002-L04-P / 1.2 CEUs

    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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Contact Us


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.

Marriott Marquis Washington, DC

901 Massachusetts Ave. NW
Washington, DC
Phone: +1 (202) 824-9200

Marriott Marquis Washington, DC
  • Accommodations

    The cut off date has now past, however reservations can still be made on a space-and-rate availabile basis. To make a reservation, please contact the Marriott Marquis Washington DC directly at +1 (202) 824-9200. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days prior to the date of arrival by 6:00 p.m. (EST) to avoid cancellation fees.

  • Amenities
    Convenience and style merge at Marriott Marquis Washington, DC. Boasting a forward-thinking design that reflects its vibrant setting, our LEED® Silver-certified convention hotel is ideally located in downtown D.C. near Penn Quarter and Chinatown. Our hotel is just blocks from the National Mall monuments and Smithsonian Museums. Stay in one of our 1,175 well-appointed rooms or 49 spacious suites enhanced with deluxe amenities. During your stay, please enjoy our complimentary bi-level fitness center. Gather with friends or colleagues, and make use of complimentary Wi-Fi, in our beautiful white marble Atrium Lobby with a 55-foot custom sculpture. Fuel up for a busy day at our six restaurants or unwind in our bars. Spanning nearly a city block, our posh hotel positions you to explore Washington, D.C. with ease.

How to Get Here

By Air

Ronald Reagan National Airport (DCA) is 4.6 miles south of the hotel, all major carriers service this airport

Washington Dulles International Airport (IAD) is 27.6 miles east, all major carriers service this airport

Baltimore Washington International Airport (BWI) is 31.7 miles southwest, all major carriers service this airport

Taxi fares from DCA are approximately $16.00 one way, not including tip, and will take about 15-20 minutes. Alternate transportation from DCA: Metro Yellow Line to Mount Vernon Square/Convention Center is approximately $1.70 (one way).

Taxi fares from IAD is approximately $80 and from BWI is about $75.

By Car

Marriott Marquis Washington, DC hotel is located at 901 Massachusetts Avenue NW, Washington, DC 20001.

Hotel Parking
Valet parking is $49 daily.

Other Options

Metro Station
Gallery Place/ Chinatown (Red Line)
0.5 miles SE from Hotel

Mt. Vernon Square 7th St. / Convention Ctr (Green & Yellow Lines)
0.1 miles E from Hotel

Train Station
Union Station
1.4 miles SE from Hotel


Registration Fees

Early Registration
Registration Type Price by February 11
Member $1,995
Non-member $2,274
Young Professional Member † $998
Gov’t/Health Auth. Member $700
Gov’t/Health Auth. Non-member $800
Academic Member $700
Academic Non-member $800
Student Member $280
Student Non-member $310

Regular Registration
Registration Type Price after February 11
Member $2,595
Non-member $2,874
Young Professional Member † $1,298
Gov’t/Health Auth. Member $700
Gov’t/Health Auth. Non-member $800
Academic Member $700
Academic Non-member $800
Student Member $280
Student Non-member $310
Tuesday/Wednesday Only
Member $1,238
Non-member $1,350

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Mar 24, 2019, no fee will be charged. After Mar 24, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Mar 24, 2019, a full refund will be given minus a $200 fee. After Mar 24, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.


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