PDA Visual Inspection Forum 2025
Navigating Breakthrough Innovations
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It’s PDA’s October Member Appreciation Week!
Save on PDA’s Visual Inspection Forum and Visual Inspection Training Courses Registration.
This week only we are offering members an additional 10%-25% registration discount off early registration fees for PDA’s Visual Inspection Forum 2025 (10% savings) and the co-joined Visual Inspection Training Courses (25% savings)* offered by PDA’s Training and Research Institute (Separate registrations).
Call for Posters
Gain visibility and build your reputation as a thought leader in your field by sharing your recent work!
Deadline: 12 January 2025
Learn More Poster SubmissionsLearn and immerse in cutting edge innovations, changes in regulatory and compendial environment and more at the PDA Visual Inspection Forum 2025
Are you ready to do a dive deep into the complex world of visual inspection (VI) for injectable medicines?
Visual inspection (VI) continues to be critical to the manufacture and delivery of high-quality injectable medicines. The regulatory and compendial environment is rapidly evolving with new and revised guidance, automated visual inspection is becoming more and more prominent, while manual inspection remains an important means of monitoring and controlling product quality. Are you aware of these changes and how they impact your practice?
Professionals across the panorama of the industry have a responsibility to stay up to date in the continuous improvements and iterations that affect their processes and practices by being informed about coming innovations to include automation.
The 26th annual PDA Visual Inspection Forum 2025 is your gateway to cutting-edge innovations, practical knowledge, keen insights, and critical industry updates.
PDA Visual Inspection Forum 2025
Are you ready to immerse yourself in the cutting-edge world of visual inspection for injectable medicines?
The 26th annual PDA Visual Inspection Forum 2025 offers a comprehensive experience that goes beyond presentations with opportunities to meet one-on-one with experts and peers who are doing valuable work.
But here’s what makes this forum truly unique in today's rapidly evolving pharmaceutical landscape:
- Do you know how visual inspection is a critical and evolving component to the manufacture and delivery of high-quality injectable medicines?
- Are you aware of, and on track with the rapid changes in the regulatory and compendial environment, including new FDA guidance, USP updates, and EU GMP Annex 1 revisions?
- Are you up to date on the latest advancements in automated visual inspection and its growing prominence in the industry?
The 26th annual PDA Visual Inspection Forum will level up your learning and immerse you in visual inspection innovations to keep your practice relevant and forward-thinking.
What’s more, the hands-on automated and manual visual inspection training courses are conveniently co-joined with the conference (separate registrations) to master practical applications of emerging scientific methods.
Why Attend the Forum?
Join this yearly preeminent gathering of industry and regulatory experts. Engage with academic researchers, innovators, and technology providers all in one place. At the PDA Visual Inspection Forum, you'll experience a unique multi-faceted learning experience:
- Regulatory Evolution: Stay current on the complex regulatory environment through expert presentations, case studies, and in-depth reviews of the latest academic research.
- Automated Inspection: Discover how technological advancements like AI in image analysis and inspection recipe development can significantly improve automated visual inspection performance. Prepare for the Forum’s dive into automated inspection by attending the Automated Inspection Training Course being held prior to the Forum.
- Manual Inspection: Learn key elements of basic inspection and sampling processes, as well as special considerations for difficult-to-inspect parenteral products. Dive further into manual inspection at the post forum Manual Inspection training course.
- Poster Sessions: Explore innovative ideas and approaches through poster presentations. Have you considered how these visual displays of cutting-edge research could inspire your own work?
- Academic Paper Reviews: Dive deeply into the latest scholarly research. How might these academic insights shape the future of visual inspection practices?
- Exhibitor Showcase: Interact with industry-leading companies showcasing their latest technologies and solutions. What new tools or services could revolutionize your inspection processes?
The learning begins by attending the Automated Visual Inspection training course preceding the Forum and continues as you put your newfound knowledge into practice in the Manual Visual Inspection training course.
Register for the ForumAutomated Visual Inspection Training Course
Here are key details on our Automated Visual Inspection Training Course, taking place before the forum.
- Apply the regulatory requirements for visual inspection to the automated environment
- Apply the knowledge of limitations of AVI inspection
- Evaluate validation strategies and be able to identify the most appropriate approach for defined circumstances
- Apply the knowledge of the functioning of AVI equipment to assess capability of performance
- Evaluate data from inspection program to identify potential program improvements and create solutions
Manual Visual Inspection Training Course
Here are key details on our Manual Visual Inspection Training Course, taking place after the forum.
- Understand current global regulatory and compendial requirements for visual inspection
- Understand patient risk associated with visible particles in injections
- Implement a technically sound and compliant inspection process
- Assess inspection performance
What You Gain
By attending both the forum and training courses, you'll walk away with:
- Comprehensive lifecycle knowledge from development to commercialization
- Risk management expertise specific to visual inspection
- Validation and verification skills for manual and automated visual inspection
- Confidence in navigating the complex landscape of global regulations
- Best practices in manual and automated visual inspection manufacturing
- Change management proficiency to adapt to industry shifts
- Immediate application of knowledge through two days of hands-on activities
- Access to industry experts and PDA's Visual Inspection Interest Group
- Insights from the latest academic research and innovative poster presentations
- Exposure to cutting-edge technologies and solutions from leading exhibitors
Get ready to transform your approach to visual inspection and ensure the highest quality standards for injectable medicines. Don't miss this unparalleled opportunity to learn, network, and grow. From plenary sessions and poster presentations to hands-on training and exhibitor demonstrations, every aspect of this event is designed to enrich your understanding and enhance your skills.
Honestly, where else can you find such a comprehensive exploration of visual inspection techniques and technologies? Register now for the forum and training courses and take the next step in your professional journey. Your patients, your organization, and your career will thank you!
Register for the forum and/or training coursesYour Forum Chairs,
Romain Veillon, GSK (Co-Chair) and Rick Watson, Merck (Co-Chair)
Contact
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Registration Customer Care
Early Registration
Register by 15 January 2025
Member Price
$1,995GovernmentMember Only
$895
StudentMember Only
$595
Non-Member
$2,395
Standard Registration
Register after 15 January 2025
Member Price
$2,495GovernmentMember Only
$995
StudentMember Only
$695
Non-Member
$2,895
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].
Monday, 10 March EDT
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Continental Breakfast
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Registration Open
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P1: Regulatory Perspectives
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Moderator: Rick J. Watson, BS Chem Eng, Director, Merck
Rick J. Watson, BS Chem Eng, Director, Merck
Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past twenty years at Merck focusing on the visual inspection processes for parenteral products. During this period, he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and glass breakage management for Merck manufacturing sites around the world.
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Welcome and Opening Remarks from Forum Co-Chairs
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Co-Chair: Romain Veillon, Director Vision Technology, GSK
Romain Veillon, Director Vision Technology, GSK
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Co-Chair: Rick J. Watson, BS Chem Eng, Director, Merck
Rick J. Watson, BS Chem Eng, Director, Merck
Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past twenty years at Merck focusing on the visual inspection processes for parenteral products. During this period, he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and glass breakage management for Merck manufacturing sites around the world.
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Visual Inspection Regulatory and Compendial Update
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Presenter: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
John is the founder of Insight Pharma Consulting, providing expert guidance in visual inspection and particle control. He began his career with The Upjohn Company responsible for process analytical technology (PAT) and visual inspection. He was Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation. He later served as Director of the Center for Advanced Sterile Technology. Before starting his consulting firm, he managed microbiology and aseptic manufacturing technical support for Pfizer’s Global Quality Operations. John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the Parenteral Drug Association, having served as chair of the Board of Directors and chair of the Science Advisory Board. He organized and co-leads the Visual Inspection Interest Group. He also instructs at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on spectroscopic analysis, PAT, rapid microbiological testing and visual inspection of pharmaceutical products. He co-authored the recently published book Visual Inspection and Particulate Control.
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Regulatory Expectations for the Assessment of Visible Particulates in Injectable Pharmaceuticals
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Presenter: Rukman S De Silva, Policy Lead, OPQ, CDER, U.S. FDA
Rukman S De Silva, Policy Lead, OPQ, CDER, U.S. FDA
Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and controls (CMC) review and inspectional activities related to biological product applications submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II. Rukman’s current responsibilities include the development of FDA policies and programs pertaining to pharmaceutical quality
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Q&A
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Networking Break in the Exhibit Hall
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Poster Presentations in the Exhibit Hall
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P2: Process Development
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Moderator: Romain Veillon, Director Vision Technology, GSK
Romain Veillon, Director Vision Technology, GSK
Already done
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Visual Inspection Challenges in Gene and Cell Therapy Production: From Clear Glass and Product to Opaque Plastic and Product
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Presenter: Ines Bauer, Expert Science & Technology, Novartis Pharmaceutical Manufacturing GmbH, Schaftenau
Ines Bauer, Expert Science & Technology, Novartis Pharmaceutical Manufacturing GmbH, Schaftenau
Ines Bauer holds a master’s degree in botany, a bachelor’s degree in biology and has an academic background in zoology. Since joining Sandoz/Novartis in 2015, she has been an integral part of the pilot plant, drug product development Schaftenau, where she focuses on visual inspection processes and has developed extensive expertise in test set creation. Over the years, her attention to detail and knowledge in these areas have significantly contributed to the success of numerous projects.
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How to Boost Your Manual Visual Inspection: A Case Study of Improving the Efficiency of MVI
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Presenter: Antonio Burazer, Global Head Visual Inspection & Particle LCM, Takeda
Antonio Burazer, Global Head Visual Inspection & Particle LCM, Takeda
Antonio Burazer joined Takeda in 2010 where he has overseen visual inspection and secondary packaging processes at a multi-product manufacturing facility in Vienna, Austria. In 2019 he transitioned to Global Quality, taking over global responsibility for visual inspection and particle life cycle management for Takeda and leading the harmonization and improvement program across 15 internal sites and 13 CMOs. He is engaged in collaborating with experts across the industry and strives for continuous improvement, guided by the ultimate goal to achieve zero particles in parenteral products.
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Networking Lunch with Exhibitors
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Interactive Questionnaire Session
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A1: New challenges in Visual Inspection Qualification
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Moderator: Andrea Sardella, PhD
Andrea Sardella, PhD
Andrea Sardella holds a degree in Physics from Padua University and a Master's in Nuclear Engineering. As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garching IPP (DE). After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial applications as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools. He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for inspection machines. Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group.
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Successful Qualification of an AI-Model for a Low-Fill Liquid Vial Particle Inspection
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Presenter: Bastian Kronenbitter, Head of Data Science, Körber Pharma Inspection GmbH
Bastian Kronenbitter, Head of Data Science, Körber Pharma Inspection GmbH
Bastian Kronenbitter is the Head of Data Science at InspectifAI, where he has led the team since April 2022. He holds a PhD in Physics from the Karlsruhe Institute of Technology (KIT), where he focused on high-energy particle physics experiments, particularly at the Belle detector. His academic background includes significant contributions to the study of CP violation, branching fractions, and B-meson decays. His work has been published in leading physics journals, including Physical Review D, and presented at international conferences such as ICHEP and PANIC. Before joining InspectifAI, Bastian held data science leadership roles at Körber Digital and Adello. He combines his expertise in data science and physics with a deep understanding of team leadership and complex systems analysis. -
Co-Presenter: Bastian Kronenbitter, Head of Data Science, Körber Pharma Inspection GmbH
Bastian Kronenbitter, Head of Data Science, Körber Pharma Inspection GmbH
Bastian Kronenbitter is the Head of Data Science at InspectifAI, where he has led the team since April 2022. He holds a PhD in Physics from the Karlsruhe Institute of Technology (KIT), where he focused on high-energy particle physics experiments, particularly at the Belle detector. His academic background includes significant contributions to the study of CP violation, branching fractions, and B-meson decays. His work has been published in leading physics journals, including Physical Review D, and presented at international conferences such as ICHEP and PANIC. Before joining InspectifAI, Bastian held data science leadership roles at Körber Digital and Adello. He combines his expertise in data science and physics with a deep understanding of team leadership and complex systems analysis.
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Qualifying an Automated Visual Inspection (AVI) Using Recirculation Function
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Presenter: Jun L. Ordonez, Sr. Manager, Pfizer
Jun L. Ordonez, Sr. Manager, Pfizer
Jun Ordonez Sr. Manager - Pfizer Gene Therapy Technical Services Drug Substance/Product – Sanford NC Direct and manage Technical Services for Gene Therapy DS/DP team performing scientific, operational and process engineering tasks related to technology transfer and routine manufacturing support. Lead in the execution optimization, implementation, troubleshooting, tracking, and reporting of a variety manufacturing processes for clinical and commercial production of gene therapy programs. Manager 2016-2021 - Pfizer Global Technology and Engineering (GT&E) – Visual Inspection SME Served as scientific and technical representative for process-related Visual Inspection (VI) issues within Pfizer network. Manage Implementation of Visual Inspection Technical Transfer to CMOs Provide sound rationale on Automated Visual Inspection (AVI) Capital requirements to obtain necessary project approval on high-cost projects and oversee multiple high capital projects that are critical to site/s operations. Provide strategies to ensure that VI programs are robust and defendable on audits and provide regulatory audit support. Provide trouble shooting, root cause analysis serving as scientific and technical expert on issues that affect AVI. Provide technical support on CMOs Visual Inspection program. Conduct assessments to multiple sites Visual Inspection Program Co-Represent Pfizer on multi-pharmaceutical industry SMEs network (BioPhorum)
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Development of a Global Standard Operating Procedure Across the Manufacturing Network for Both Liquid and Difficult to Inspect Parenterals Case Study
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Presenter: Pere Joaquin, Director of Site Quality and QP, Reig Jofre
Pere Joaquin, Director of Site Quality and QP, Reig Jofre
Degree in pharmacy, MSc in pharmaceutical industry and postgraduate in clinical nutrition. Experience in Regulatory Affairs and Pharmacovigilance. Experience in aseptic manufacturing and Quality Assurance at B.Braun Spain (Barcelona area) manufacturing site for more than 7 years. Joined Labiana Pharmaceuticals as Deputy QP and subsequently Quality Unit Director and main Qualified Person of a sterile and aseptic manufacturing site (freeze dried, aseptic, sterile, both ampoules and vials, sterile eye drops), also solid and liquid oral forms. Followed by Neuraxpharm manufacturing site (sterile eye drops and solid oral forms) as Quality Unit Director and QP of the site for almost a year. Most recent role, I joined Laboratorio Reig Jofre in Barcelona and I performed my actual role as Quality Unit Director and main QP of this sterile and aseptic manufacturing site (freeze dried and liquid aseptic and sterile vials and liquid ampoules), also solid and liquid oral forms and topical forms for more than 3 years up to date.
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Q&A
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B1: Advances in Particle Investigations
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Moderator: Robert J Miller, Director, Technical Services, Pfizer Inc
Robert J Miller, Director, Technical Services, Pfizer Inc
TBD
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Problem Solving During Trace Foreign Matter Investigations: Points to Consider
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Presenter: Mary Lee Ciolkowski, PhD, Sr. Principal Scientist, Bausch + Lomb
Mary Lee Ciolkowski, PhD, Sr. Principal Scientist, Bausch + Lomb
Mary Lee Ciolkowski is a Sr. Principal Scientist at Bausch + Lomb and has 20+ years of experience spanning R&D through product launch and on-going manufacturing support. Mary Lee is an SME in the characterization of sub-visible and visible particles in pharmaceutical dosage forms during development and drug product quality control/stability studies. This includes support of particle-related root-cause analyses and investigations at US and global manufacturing sites. Mary Lee also supports visual inspection training and ensuring compliant visual inspection systems are implemented at manufacturing sites. Mary Lee is a member of the USP1790 and USP788 Expert Panels.
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Achieving Particle Reduction via Supplier Contamination Control Strategies and Innovation in RTF Packaging
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Presenter: Colleen O'Brien, MS, Strategy and Technical Affairs, Gerresheimer
Colleen O'Brien, MS, Strategy and Technical Affairs, Gerresheimer
Colleen O'Brien has more than 20yrs of experience in pharmaceutical manufacturing and primary packaging as a subject matter expert for fill finish of injectable drugs. She holds a BS in Biochemistry from Albright College, a MS in Manufacturing Systems Engineering from Lehigh University, and is currently an MBA candidate at Lehigh University. She has held various roles including Senior Aseptic Operator,Technology Transfer Engineer, Validation Specialist, and Business Development Manager. Her previous companies include sanofi pasteur, Merck, Jubilant HollisterStier, Schott, and Gerresheimer.
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Cellulose - Understanding and Narrowing Down its Sources
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Presenter: Casey M Jarvis, Research Scientist, MVA Scientific Consultants
Casey M Jarvis, Research Scientist, MVA Scientific Consultants
Casey is the lead expert at MVA Scientific Consultants for pharmaceutical and biomedical testing. She is one of MVA’s executive directors and project leaders, bridging communication between the client and the scientist. Casey is a chemist with experience in particle isolation and characterization, material analysis, and investigative analysis. She works with a variety of microscopes and complementary techniques to provide comprehensive results and supporting data. Fourier transform infrared spectroscopy (FTIR) and confocal Raman microscopy (CRM) are Casey’s specialties. Casey commits to quality through technical review and as deputy of MVA’s quality team.
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Q&A
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Networking Break in the Exhibit Hall
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Poster Presentations in the Exhibit Hall
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A2: Particle Detection Capability
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Moderator: Rukman S De Silva, Policy Lead, OPQ, CDER, U.S. FDA
Rukman S De Silva, Policy Lead, OPQ, CDER, U.S. FDA
Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and controls (CMC) review and inspectional activities related to biological product applications submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II. Rukman’s current responsibilities include the development of FDA policies and programs pertaining to pharmaceutical quality
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Beyond Size and Shape: The Role of Color in Particle Detection
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Presenter: Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
Atanas Koulov, PhD, Chief Scientific Officer, Clear Solutions Laboratories AG
Atanas Koulov has extensive experience in pharmaceutical drug product development and manufacturing from Roche/Genentech, Novartis and Lonza. His focus areas are drug product control strategies, particle contamination and quality control. He has authored more than 50 scientific publications and book chapters. He is a co-founder and Chief Scientific Officer or Clear Solutions Laboratories AG.
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3D Printed Protein-Like Model Particles as Particle Standards for Performance Evaluation of Novel Human-Inspired Automated Visual Inspection Instrument
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Presenter: Oliver Germershaus, Professor, University of Applied Sciences Northwestern Switzerland
Oliver Germershaus, Professor, University of Applied Sciences Northwestern Switzerland
Oliver Germershaus is Professor of Pharmaceutics of Macromolecular Drugs at University of Applied Sciences Northwestern Switzerland focussing on research and development in the field of biologics formulation and processing, drug delivery system development and parenteral packaging and device development. In recent years special emphasis was on development of novel particle standards, specifically designed to match the appearance and behaviour of protein particles. Furthermore, evaluation of container-closure integrity, especially at frozen and cryogenic storage conditions is a current focus topic.
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Case Studies: Increasing PoD in MVI for DIP
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Co-Presenter: Menno Sels, MSE, Project Engineer VI & CCIT, eyetec
Menno Sels, MSE, Project Engineer VI & CCIT, eyetec
Graduated Chemical Engineer involved in several GMP projects in the past 5 years. First hand experience in managing Visual Inspection projects from A to Z. Determined problem-solver and analytical thinker. -
Presenter: Bram J.J. KEYMOLEN, Co-Founder, eyetec
Bram J.J. KEYMOLEN, Co-Founder, eyetec
Graduated pharmacist at the university of Antwerp, Bram Keymolen obtained a second master degree in Industrial Pharmacy in 1999. Over twenty years of GMP experience in different roles, initially mainly in qualification and validation, evolving into several QA and QP positions in mainly biotech companies – both startups and corporate structures. After taking a position as Process Engineer in the field of visual inspection in 2006, created his own consultancy company in this domain in 2011. Eye-Tec supports visual inspection and CCIT projects under GMP. Missions vary from CAPA-development to major CAPEX projects or corporate strategy development for visual inspection and CCIT. Eye-Tec offers both technical solutions (vision tuning and optical/mechanical improvement) and compliance support to customers worldwide.
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Q&A
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B2: Novel AI-Based Equipment for Difficult-to-Inspect Products
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Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG
Linda Wildling did her Ph.D. and Post-Doc research at the Institute for Biophysics at the University of Linz in Cell Communication in the Health and Disease field. In 2011 she joined Takeda Pharmaceuticals and worked in several positions within Takeda Site Quality and Production. She has broad experience in Pharmaceutical development, Auditing, Regulatory & CMC, and Contract Manufacturing management, including sterile production and lyophilized products. Linda works in Digital within Takeda Manufacturing as Head of Digital Innovation Success Management. To drive digital innovation, she is also leading the project AI-enabled, automated inspection of lyophilized products in sterile pharmaceutical manufacturing. She is the Co-Lead of Takeda´s Global Visual Inspection Program - Visual Inspection in Parenterals and Particles Management.
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Difference Between Rule-Based and AI Algorithms in the Quality Control of Difficult-to-Inspect Parenterals
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Presenter: Matthias Kahl, Head of R&D and Lab Services, WILCO AG
Matthias Kahl, Head of R&D and Lab Services, WILCO AG
Dr. Matthias Kahl has been Head of the Research, Development and Laboratory Services of WILCO AG in Wohlen since 2018. He started in 2017 as responsible for development of new technologies. After studying physics at the University of Erlangen in the field of solid state physics and physical metrology, he obtained his doctorate in modern optics and laser technology at the University of Konstanz in 2006. This was followed by a position as deputy development manager in the field of high-precision material processing with lasers. Further tasks include innovation management, intellectual property issues, and collaboration in quality management.
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Enhancing Image Classification and Reducing False Rejection Rates in BFS DIP Products Using AI on AVI systems
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Presenter: GIANMARCO PINCELLI, Technical Sales Manager, Bonfiglioli Engineering srl
GIANMARCO PINCELLI, Technical Sales Manager, Bonfiglioli Engineering srl
Gianmarco Pincelli is currently in charge as Technical Sales Manager at Bonfiglioli Engineering, which is part of TASITEST Group. He received its degree in Mechanical and Specialization on Machinery Technical Documentation in Ferrara (Italy) in 1998, and after some work experiences as a freelance for different Mechanical Design Offices, in 1999 he joined Bonfiglioli Engineering. Devoting his professional life, at the beginning as Mechanical Designer Pharma Specialist and shifted progressively to Pharmaceutical Application Team Leader and to Design Team Manager in 2010 till 2019. Now he moved to the Sales, being responsible for Sales Network & worldwide agencies technical training, and giving assistance in customized projects; he also represents BE company at PDA events as well as other congresses and exhibitions.
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Unsupervised Machine Learning Applied to Difficult-to-Inspect Products
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Presenter: Brian Turnquist, PhD, Chief Technical Officer, Boon Logic
Brian Turnquist, PhD, Chief Technical Officer, Boon Logic
Brian Turnquist is Chief Technical Officer of Boon Logic, an AI software company in Minneapolis specializing in applying unsupervised machine learning in regulated industries and mission critical applications. Turnquist received his PhD in mathematics from the University of Maryland in 1997 and spent most of his career in neuroscience developing techniques for automated classification of neural activity, with full-time positions at Johns Hopkins University, Bethel University, and visiting research appointments at the Universities of Nürnberg and Heidelberg. At Boon Logic, Turnquist has applied these techniques to computer vision-based anomaly detection, leading to the development of novel, AI-based technologies for visual inspection of parenterals.
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Q&A
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Networking Reception in Exhibit Hall
Tuesday, 11 March EDT
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Continental Breakfast
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Registration Open
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P3: Visual Inspection Acceptance Sampling and Performance Measurement
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Moderator: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
John is the founder of Insight Pharma Consulting, providing expert guidance in visual inspection and particle control. He began his career with The Upjohn Company responsible for process analytical technology (PAT) and visual inspection. He was Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation. He later served as Director of the Center for Advanced Sterile Technology. Before starting his consulting firm, he managed microbiology and aseptic manufacturing technical support for Pfizer’s Global Quality Operations. John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the Parenteral Drug Association, having served as chair of the Board of Directors and chair of the Science Advisory Board. He organized and co-leads the Visual Inspection Interest Group. He also instructs at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on spectroscopic analysis, PAT, rapid microbiological testing and visual inspection of pharmaceutical products. He co-authored the recently published book Visual Inspection and Particulate Control.
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Sampling in the Visual Inspection Process: AQL and Defect Trending
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Presenter: Robert J Miller, Director, Technical Services, Pfizer Inc
Robert J Miller, Director, Technical Services, Pfizer Inc
TBD
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Use of Mathematical Model for Detection Performances Comparison of MVI versus AVI
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Presenter: Mitsutaka Shirasaki, Principal Engineer, Genentech Inc.
Mitsutaka Shirasaki, Principal Engineer, Genentech Inc.
Mitsutaka Shirasaki is a Principal Engineer at Genentech/Roche with 24 years of experience in the visual inspection field. His career started with Eisai Machinery (currently Syntegon Pharmaceutical Technology) as a field service Engineer and worked with many companies in the industry for qualification of AVI equipment. He is a member of the BioPhorum VI workstream and published multiple industry guidance papers along with other esteemed authors. He is passionate about advancing the VI technologies and developing more effective methods of AVI qualification.
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Q&A
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Networking Break in the Exhibit Hall
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Poster Presentations in the Exhibit Hall
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A3: Inspection Optimization
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Moderator: Markus Adlberger, MSc, Product Owner Visual Inspection Software, Körber Pharma
Markus Adlberger, MSc, Product Owner Visual Inspection Software, Körber Pharma
Markus Adlberger is the Product Owner for Visual Inspection Software at Körber Pharma Inspection in Markt Schwaben, Germany. He has over 15 years of experience in the visual inspection of pharmaceutical products, both within Körber Pharma Inspection and the pharmaceutical industry. In his current role, he is responsible for the ongoing development of the Visual Inspection Software and manages the requirements from external and internal customers, ensuring continuous innovation and maintaining high standards in pharmaceutical visual inspection.
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Modernization of an MVI Program to Improve Defect Detection
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David B Wetherington, Sr. Manager, Operations (Visual Inspection and Packaging), Thermo Fisher Scientific
Blaine Wetherington Senior Manager of Operations (inspection and Packaging) at Patheon, a part of Thermo Fisher Scientific) 17 years of pharmaceutical industry experience spanning multiple roles and responsibilities including industrial engineering, continuous improvement and operations.
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Revolutionizing Pharmaceutical Inspection: Upgrading to Automated Visual Inspection Systems
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Presenter: Scott Council, North Carolina Division Director, Performance Validation
Scott Council, North Carolina Division Director, Performance Validation
Scott is a senior leader with 20+ years of progressive operations leadership, including 20 years in the biomedical/pharmaceutical industry. Leverages strong drive for customer satisfaction, building of high performing teams, analytical decision-making perspective, excellent communication, and diverse problem-solving skills to accomplish business goals and propel technical innovation. -
Co-Presenter: Bill Waterstreet, Principal Validation Engineer, Performance Validation
Bill Waterstreet, Principal Validation Engineer, Performance Validation
Bill has supported cGMP compliance projects for the pharmaceutical industry since 2015. Has experience in the development of validation documentation and specifications for equipment including the associated control systems. Has also supported building commissioning for both new construction and building renovations. Experience includes facilities, clean utilities, dirty utilities, HVACR, and inspection equipment.
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Manual Visual Inspection (MVI) and Inspector Training and Qualification
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Presenter: Tracey Sinjen, Principal Consultant, Lachman Consultants
Tracey Sinjen, Principal Consultant, Lachman Consultants
tbd
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Q&A
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B3: Novel Inspection Equipment Design and Application
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Moderator: Rick J. Watson, BS Chem Eng, Director, Merck
Rick J. Watson, BS Chem Eng, Director, Merck
Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past twenty years at Merck focusing on the visual inspection processes for parenteral products. During this period, he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and glass breakage management for Merck manufacturing sites around the world.
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AI-Driven Visual Inspection: Unlocking Data for Smarter Production
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Presenter: Massimo Frasson, Ceo & General Manager, BREVETTI C.E.A. S.p.A.
Massimo Frasson, Ceo & General Manager, BREVETTI C.E.A. S.p.A.
Mr. Massimo Frasson holds a Master's Degree in Mechanical Engineering and has a successful career in the automation industry. He began his journey with Brevetti C.E.A. in 2000 as the Mechanic Systems Design Manager and progressively assumed more significant roles. In 2007, he played a pivotal role in Brevetti C.E.A.'s restructuring and the introduction of new vision technologies. Simultaneously, he led a department focused on pharmaceutical process analysis using artificial vision systems and neural algorithms. In 2010, Mr. Massimo Frasson took on the responsibility for the entire operations process and was appointed General Manager in February 2014. His leadership and dedication led to his promotion to CEO in 2019. Today, he continues to drive Brevetti C.E.A.'s growth and development with his extensive industry knowledge and commitment to excellence.
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A Semi-Automated IV Bag Inspection System (IVBIS)
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Presenter: Neil Jesse Hamilton, Vice President Technical Services, AWS Bio-Pharma Technologies LLC
Neil Jesse Hamilton, Vice President Technical Services, AWS Bio-Pharma Technologies LLC
Please join AWS in welcoming Neil Hamilton as Vice President of Technical Services. Neil is a veteran of the United States Air Force where he received an honorable discharge. He has many years of experience as a project engineer for CAD design and test engineering. Much of his project work was heavily involved with R&D and innovation management. His background includes aircraft mechanical work, aerospace gunfire testing, spacecraft systems design, design of new construction products and fire testing of construction products. Neil has also worked in the pharmaceutical industry as a QA lab engineer where he used Good Manufacturing Practices and Good Documentation Practices while commissioning new laboratory equipment. While at AWS Bio-Pharma Neil has designed components of the IVBIS (IV Bag Inspection System), performed fluid mechanics calculations for a WFI loop, checked drawings, built modular cleanrooms, and other hands on and engineering tasks. He also sourced the camera and video system for the IVBIS system. Additionally, he has assisted as an inside sales professional doing cold calling and writing quotes.
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The Next Phase in Visual Inspection – Complete Electronic Records
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Presenter: Gerlad Budd, President, Phoenix Imaging Ltd.
Gerlad Budd, President, Phoenix Imaging Ltd.
Holds BS in Physics & Chemistry (principal area of study Optics), MS in Quality Systems. Founder of Phoenix Imaging companies in 1985 with multiple patents in manual and automated inspection systems. Over 40 years' experience in machine vision technology specializing in high resolution 3-D measurements. Design and manufacture of Manual Inspection Booths since 1999.
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Q&A
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Networking Lunch with Exhibitors
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Interactive Questionnaire Session
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P4: Visual Inspection Process Development and Qualification
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Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG
Linda Wildling did her Ph.D. and Post-Doc research at the Institute for Biophysics at the University of Linz in Cell Communication in the Health and Disease field. In 2011 she joined Takeda Pharmaceuticals and worked in several positions within Takeda Site Quality and Production. She has broad experience in Pharmaceutical development, Auditing, Regulatory & CMC, and Contract Manufacturing management, including sterile production and lyophilized products. Linda works in Digital within Takeda Manufacturing as Head of Digital Innovation Success Management. To drive digital innovation, she is also leading the project AI-enabled, automated inspection of lyophilized products in sterile pharmaceutical manufacturing. She is the Co-Lead of Takeda´s Global Visual Inspection Program - Visual Inspection in Parenterals and Particles Management.
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Visual Inspection Validation Considerations for Traditional and New Technology
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Presenter: Rick J. Watson, BS Chem Eng, Director, Merck
Rick J. Watson, BS Chem Eng, Director, Merck
Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past twenty years at Merck focusing on the visual inspection processes for parenteral products. During this period, he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and glass breakage management for Merck manufacturing sites around the world.
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Benefit of Digital Visual Inspection Platform
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Presenter: Romain Veillon, Director Vision Technology, GSK
Romain Veillon, Director Vision Technology, GSK
Already done
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Q&A
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Networking Break in the Exhibit Hall
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Poster Presentations in the Exhibit Hall
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P5: Panel Discussion
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Moderator: Romain Veillon, Director Vision Technology, GSK
Romain Veillon, Director Vision Technology, GSK
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Moderator: Rick J. Watson, BS Chem Eng, Director, Merck
Rick J. Watson, BS Chem Eng, Director, Merck
Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past twenty years at Merck focusing on the visual inspection processes for parenteral products. During this period, he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and glass breakage management for Merck manufacturing sites around the world.
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Panel Discussion
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Panelist: Markus Adlberger, MSc, Product Owner Visual Inspection Software, Körber Pharma
Markus Adlberger, MSc, Product Owner Visual Inspection Software, Körber Pharma
Markus Adlberger is the Product Owner for Visual Inspection Software at Körber Pharma Inspection in Markt Schwaben, Germany. He has over 15 years of experience in the visual inspection of pharmaceutical products, both within Körber Pharma Inspection and the pharmaceutical industry. In his current role, he is responsible for the ongoing development of the Visual Inspection Software and manages the requirements from external and internal customers, ensuring continuous innovation and maintaining high standards in pharmaceutical visual inspection. -
Panelist: Rukman S De Silva, Policy Lead, OPQ, CDER, U.S. FDA
Rukman S De Silva, Policy Lead, OPQ, CDER, U.S. FDA
Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and controls (CMC) review and inspectional activities related to biological product applications submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II. Rukman’s current responsibilities include the development of FDA policies and programs pertaining to pharmaceutical quality -
Panelist: Robert J Miller, Director, Technical Services, Pfizer Inc
Robert J Miller, Director, Technical Services, Pfizer Inc
TBD -
Panelist: Andrea Sardella, PhD
Andrea Sardella, PhD
Andrea Sardella holds a degree in Physics from Padua University and a Master's in Nuclear Engineering. As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garching IPP (DE). After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial applications as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools. He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for inspection machines. Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group. -
Panelist: John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
John G Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
John is the founder of Insight Pharma Consulting, providing expert guidance in visual inspection and particle control. He began his career with The Upjohn Company responsible for process analytical technology (PAT) and visual inspection. He was Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation. He later served as Director of the Center for Advanced Sterile Technology. Before starting his consulting firm, he managed microbiology and aseptic manufacturing technical support for Pfizer’s Global Quality Operations. John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the Parenteral Drug Association, having served as chair of the Board of Directors and chair of the Science Advisory Board. He organized and co-leads the Visual Inspection Interest Group. He also instructs at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on spectroscopic analysis, PAT, rapid microbiological testing and visual inspection of pharmaceutical products. He co-authored the recently published book Visual Inspection and Particulate Control. -
Panelist: Romain Veillon, Director Vision Technology, GSK
Romain Veillon, Director Vision Technology, GSK
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Panelist: Rick J. Watson, BS Chem Eng, Director, Merck
Rick J. Watson, BS Chem Eng, Director, Merck
Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past twenty years at Merck focusing on the visual inspection processes for parenteral products. During this period, he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and glass breakage management for Merck manufacturing sites around the world. -
Linda Wildling, PhD, Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG
Linda Wildling did her Ph.D. and Post-Doc research at the Institute for Biophysics at the University of Linz in Cell Communication in the Health and Disease field. In 2011 she joined Takeda Pharmaceuticals and worked in several positions within Takeda Site Quality and Production. She has broad experience in Pharmaceutical development, Auditing, Regulatory & CMC, and Contract Manufacturing management, including sterile production and lyophilized products. Linda works in Digital within Takeda Manufacturing as Head of Digital Innovation Success Management. To drive digital innovation, she is also leading the project AI-enabled, automated inspection of lyophilized products in sterile pharmaceutical manufacturing. She is the Co-Lead of Takeda´s Global Visual Inspection Program - Visual Inspection in Parenterals and Particles Management.
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Closing Remarks from Forum Co-Chairs
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Co-Chair: Romain Veillon, Director Vision Technology, GSK
Romain Veillon, Director Vision Technology, GSK
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Co-Chair: Rick J. Watson, BS Chem Eng, Director, Merck
Rick J. Watson, BS Chem Eng, Director, Merck
Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past twenty years at Merck focusing on the visual inspection processes for parenteral products. During this period, he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and glass breakage management for Merck manufacturing sites around the world.
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Presenters
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Markus Adlberger, MSc
Product Owner Visual Inspection Software, Körber Pharma
Moderator
Panelist
Read BioMarkus Adlberger, MSc
Körber Pharma
Markus Adlberger is the Product Owner for Visual Inspection Software at Körber Pharma Inspection in Markt Schwaben, Germany. He has over 15 years of experience in the visual inspection of pharmaceutical products, both within Körber Pharma Inspection and the pharmaceutical industry. In his current role, he is responsible for the ongoing development of the Visual Inspection Software and manages the requirements from external and internal customers, ensuring continuous innovation and maintaining high standards in pharmaceutical visual inspection. -
Ines Bauer
Expert Science & Technology, Novartis Pharmaceutical Manufacturing GmbH, Schaftenau
Presenter
Read BioInes Bauer
Novartis Pharmaceutical Manufacturing GmbH, Schaftenau
Ines Bauer holds a master’s degree in botany, a bachelor’s degree in biology and has an academic background in zoology. Since joining Sandoz/Novartis in 2015, she has been an integral part of the pilot plant, drug product development Schaftenau, where she focuses on visual inspection processes and has developed extensive expertise in test set creation. Over the years, her attention to detail and knowledge in these areas have significantly contributed to the success of numerous projects. -
Gerlad Budd
President, Phoenix Imaging Ltd.
Presenter
Read BioGerlad Budd
Phoenix Imaging Ltd.
Holds BS in Physics & Chemistry (principal area of study Optics), MS in Quality Systems. Founder of Phoenix Imaging companies in 1985 with multiple patents in manual and automated inspection systems. Over 40 years' experience in machine vision technology specializing in high resolution 3-D measurements. Design and manufacture of Manual Inspection Booths since 1999. -
Antonio Burazer
Global Head Visual Inspection & Particle LCM, Takeda
Presenter
Read BioAntonio Burazer
Takeda
Antonio Burazer joined Takeda in 2010 where he has overseen visual inspection and secondary packaging processes at a multi-product manufacturing facility in Vienna, Austria. In 2019 he transitioned to Global Quality, taking over global responsibility for visual inspection and particle life cycle management for Takeda and leading the harmonization and improvement program across 15 internal sites and 13 CMOs. He is engaged in collaborating with experts across the industry and strives for continuous improvement, guided by the ultimate goal to achieve zero particles in parenteral products. -
Mary Lee Ciolkowski, PhD
Sr. Principal Scientist, Bausch + Lomb
Presenter
Read BioMary Lee Ciolkowski, PhD
Bausch + Lomb
Mary Lee Ciolkowski is a Sr. Principal Scientist at Bausch + Lomb and has 20+ years of experience spanning R&D through product launch and on-going manufacturing support. Mary Lee is an SME in the characterization of sub-visible and visible particles in pharmaceutical dosage forms during development and drug product quality control/stability studies. This includes support of particle-related root-cause analyses and investigations at US and global manufacturing sites. Mary Lee also supports visual inspection training and ensuring compliant visual inspection systems are implemented at manufacturing sites. Mary Lee is a member of the USP1790 and USP788 Expert Panels. -
Scott Council
North Carolina Division Director, Performance Validation
Presenter
Read BioScott Council
Performance Validation
Scott is a senior leader with 20+ years of progressive operations leadership, including 20 years in the biomedical/pharmaceutical industry. Leverages strong drive for customer satisfaction, building of high performing teams, analytical decision-making perspective, excellent communication, and diverse problem-solving skills to accomplish business goals and propel technical innovation. -
Rukman S De Silva
Policy Lead, OPQ, CDER, U.S. FDA
Moderator
Panelist
Presenter
Read BioRukman S De Silva
U.S. FDA
Rukman De Silva, Ph.D. is currently working as a Policy Lead in the U.S. Food and Drug Administration (FDA)/ Center for Drug Evaluation and Research (CDER)/ Office of Pharmaceutical Quality (OPQ)/ Office of Policy for Pharmaceutical Quality (OPPQ)/ Division of Internal Policies and Communications (DIPAC), Branch II. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008, he joined FDA/CDER/OPQ/Office of Biotechnology Products (OBP). At OBP, he conducted chemistry manufacturing and controls (CMC) review and inspectional activities related to biological product applications submitted to the FDA. In 2022, he joined FDA/CDER/OPQ/OPPQ/DIPAC, Branch II. Rukman’s current responsibilities include the development of FDA policies and programs pertaining to pharmaceutical quality -
Christy Eatmon
Global SME Sterile Drug Products, Thermo Fisher Scientific
Presenter
Read BioChristy Eatmon
Thermo Fisher Scientific
Christy Eatmon is the Global SME for Sterile Drug Products at Thermo Fisher Scientific, a role she has held since January 2019. With over 15 years of experience in the pharmaceutical industry, Christy specializes in process optimization, product development, and manufacturing, with a focus on sterile filling. She has extensive expertise in all phases of drug development, from discovery to commercial manufacturing. Her areas of specialization include tech transfer, scale-up, process validation, and small molecule formulation for controlled release. Christy holds a degree from Moravian University and has been instrumental in driving product innovations and ensuring patient-centric solutions in global pharmaceutical projects. Before joining Thermo Fisher, she served as a Formulation Scientist at Particle Sciences, A Lubrizol Company. Christy regularly contributes her insights at major industry conferences, including DCAT and CPHI. -
Massimo Frasson
Ceo & General Manager, BREVETTI C.E.A. S.p.A.
Presenter
Read BioMassimo Frasson
BREVETTI C.E.A. S.p.A.
Mr. Massimo Frasson holds a Master's Degree in Mechanical Engineering and has a successful career in the automation industry. He began his journey with Brevetti C.E.A. in 2000 as the Mechanic Systems Design Manager and progressively assumed more significant roles. In 2007, he played a pivotal role in Brevetti C.E.A.'s restructuring and the introduction of new vision technologies. Simultaneously, he led a department focused on pharmaceutical process analysis using artificial vision systems and neural algorithms. In 2010, Mr. Massimo Frasson took on the responsibility for the entire operations process and was appointed General Manager in February 2014. His leadership and dedication led to his promotion to CEO in 2019. Today, he continues to drive Brevetti C.E.A.'s growth and development with his extensive industry knowledge and commitment to excellence. -
Oliver Germershaus
Professor, University of Applied Sciences Northwestern Switzerland
Presenter
Read BioOliver Germershaus
University of Applied Sciences Northwestern Switzerland
Oliver Germershaus is Professor of Pharmaceutics of Macromolecular Drugs at University of Applied Sciences Northwestern Switzerland focussing on research and development in the field of biologics formulation and processing, drug delivery system development and parenteral packaging and device development. In recent years special emphasis was on development of novel particle standards, specifically designed to match the appearance and behaviour of protein particles. Furthermore, evaluation of container-closure integrity, especially at frozen and cryogenic storage conditions is a current focus topic. -
Neil Jesse Hamilton
Vice President Technical Services, AWS Bio-Pharma Technologies LLC
Presenter
Read BioNeil Jesse Hamilton
AWS Bio-Pharma Technologies LLC
Please join AWS in welcoming Neil Hamilton as Vice President of Technical Services. Neil is a veteran of the United States Air Force where he received an honorable discharge. He has many years of experience as a project engineer for CAD design and test engineering. Much of his project work was heavily involved with R&D and innovation management. His background includes aircraft mechanical work, aerospace gunfire testing, spacecraft systems design, design of new construction products and fire testing of construction products. Neil has also worked in the pharmaceutical industry as a QA lab engineer where he used Good Manufacturing Practices and Good Documentation Practices while commissioning new laboratory equipment. While at AWS Bio-Pharma Neil has designed components of the IVBIS (IV Bag Inspection System), performed fluid mechanics calculations for a WFI loop, checked drawings, built modular cleanrooms, and other hands on and engineering tasks. He also sourced the camera and video system for the IVBIS system. Additionally, he has assisted as an inside sales professional doing cold calling and writing quotes. -
Casey M Jarvis
Research Scientist, MVA Scientific Consultants
Presenter
Read BioCasey M Jarvis
MVA Scientific Consultants
Casey is the lead expert at MVA Scientific Consultants for pharmaceutical and biomedical testing. She is one of MVA’s executive directors and project leaders, bridging communication between the client and the scientist. Casey is a chemist with experience in particle isolation and characterization, material analysis, and investigative analysis. She works with a variety of microscopes and complementary techniques to provide comprehensive results and supporting data. Fourier transform infrared spectroscopy (FTIR) and confocal Raman microscopy (CRM) are Casey’s specialties. Casey commits to quality through technical review and as deputy of MVA’s quality team. -
Pere Joaquin
Director of Site Quality and QP, Reig Jofre
Presenter
Read BioPere Joaquin
Reig Jofre
Degree in pharmacy, MSc in pharmaceutical industry and postgraduate in clinical nutrition. Experience in Regulatory Affairs and Pharmacovigilance. Experience in aseptic manufacturing and Quality Assurance at B.Braun Spain (Barcelona area) manufacturing site for more than 7 years. Joined Labiana Pharmaceuticals as Deputy QP and subsequently Quality Unit Director and main Qualified Person of a sterile and aseptic manufacturing site (freeze dried, aseptic, sterile, both ampoules and vials, sterile eye drops), also solid and liquid oral forms. Followed by Neuraxpharm manufacturing site (sterile eye drops and solid oral forms) as Quality Unit Director and QP of the site for almost a year. Most recent role, I joined Laboratorio Reig Jofre in Barcelona and I performed my actual role as Quality Unit Director and main QP of this sterile and aseptic manufacturing site (freeze dried and liquid aseptic and sterile vials and liquid ampoules), also solid and liquid oral forms and topical forms for more than 3 years up to date. -
Matthias Kahl
Head of R&D and Lab Services, WILCO AG
Presenter
Read BioMatthias Kahl
WILCO AG
Dr. Matthias Kahl has been Head of the Research, Development and Laboratory Services of WILCO AG in Wohlen since 2018. He started in 2017 as responsible for development of new technologies. After studying physics at the University of Erlangen in the field of solid state physics and physical metrology, he obtained his doctorate in modern optics and laser technology at the University of Konstanz in 2006. This was followed by a position as deputy development manager in the field of high-precision material processing with lasers. Further tasks include innovation management, intellectual property issues, and collaboration in quality management. -
Bram J.J. KEYMOLEN
Co-Founder, eyetec
Presenter
Read BioBram J.J. KEYMOLEN
eyetec
Graduated pharmacist at the university of Antwerp, Bram Keymolen obtained a second master degree in Industrial Pharmacy in 1999. Over twenty years of GMP experience in different roles, initially mainly in qualification and validation, evolving into several QA and QP positions in mainly biotech companies – both startups and corporate structures. After taking a position as Process Engineer in the field of visual inspection in 2006, created his own consultancy company in this domain in 2011. Eye-Tec supports visual inspection and CCIT projects under GMP. Missions vary from CAPA-development to major CAPEX projects or corporate strategy development for visual inspection and CCIT. Eye-Tec offers both technical solutions (vision tuning and optical/mechanical improvement) and compliance support to customers worldwide. -
Atanas Koulov, PhD
Chief Scientific Officer, Clear Solutions Laboratories AG
Presenter
Read BioAtanas Koulov, PhD
Clear Solutions Laboratories AG
Atanas Koulov has extensive experience in pharmaceutical drug product development and manufacturing from Roche/Genentech, Novartis and Lonza. His focus areas are drug product control strategies, particle contamination and quality control. He has authored more than 50 scientific publications and book chapters. He is a co-founder and Chief Scientific Officer or Clear Solutions Laboratories AG. -
Bastian Kronenbitter
Head of Data Science, Körber Pharma Inspection GmbH
Co-Presenter
Read BioBastian Kronenbitter
Körber Pharma Inspection GmbH
Bastian Kronenbitter is the Head of Data Science at InspectifAI, where he has led the team since April 2022. He holds a PhD in Physics from the Karlsruhe Institute of Technology (KIT), where he focused on high-energy particle physics experiments, particularly at the Belle detector. His academic background includes significant contributions to the study of CP violation, branching fractions, and B-meson decays. His work has been published in leading physics journals, including Physical Review D, and presented at international conferences such as ICHEP and PANIC. Before joining InspectifAI, Bastian held data science leadership roles at Körber Digital and Adello. He combines his expertise in data science and physics with a deep understanding of team leadership and complex systems analysis. -
Paul Mason, PhD
Executive Director, Lachman Consultants
Presenter
Read BioPaul Mason, PhD
Lachman Consultants
Paul Mason, Ph.D., is an Executive Director at Lachman Consultants who has 20+ years of experience in the pharmaceutical industry. He is a Quality Control chemist experienced in sterile parenteral, API, and solid oral dosage forms. His experience spans finished dosage form, CMOs, and API (intermediates) manufacture support in both a Quality Control and Analytical Development setting. Dr. Mason possesses a deep understanding of business strategy relating to drug research, development, quality assurance, quality control, CMC submissions, laboratory design, clinical and pre-clinical quality/analytical development support. In addition, he has provided expert scientific support for the timely resolution of complicated scientific issues raised by FDA application reviewers. -
Robert J Miller
Director, Technical Services, Pfizer Inc
Moderator
Panelist
Presenter
Read BioRobert J Miller
Pfizer Inc
TBD -
Colleen O'Brien, MS
Strategy and Technical Affairs, Gerresheimer
Presenter
Read BioColleen O'Brien, MS
Gerresheimer
Colleen O'Brien has more than 20yrs of experience in pharmaceutical manufacturing and primary packaging as a subject matter expert for fill finish of injectable drugs. She holds a BS in Biochemistry from Albright College, a MS in Manufacturing Systems Engineering from Lehigh University, and is currently an MBA candidate at Lehigh University. She has held various roles including Senior Aseptic Operator,Technology Transfer Engineer, Validation Specialist, and Business Development Manager. Her previous companies include sanofi pasteur, Merck, Jubilant HollisterStier, Schott, and Gerresheimer. -
Jun L. Ordonez
Sr. Manager, Pfizer
Presenter
Read BioJun L. Ordonez
Pfizer
Jun Ordonez Sr. Manager - Pfizer Gene Therapy Technical Services Drug Substance/Product – Sanford NC Direct and manage Technical Services for Gene Therapy DS/DP team performing scientific, operational and process engineering tasks related to technology transfer and routine manufacturing support. Lead in the execution optimization, implementation, troubleshooting, tracking, and reporting of a variety manufacturing processes for clinical and commercial production of gene therapy programs. Manager 2016-2021 - Pfizer Global Technology and Engineering (GT&E) – Visual Inspection SME Served as scientific and technical representative for process-related Visual Inspection (VI) issues within Pfizer network. Manage Implementation of Visual Inspection Technical Transfer to CMOs Provide sound rationale on Automated Visual Inspection (AVI) Capital requirements to obtain necessary project approval on high-cost projects and oversee multiple high capital projects that are critical to site/s operations. Provide strategies to ensure that VI programs are robust and defendable on audits and provide regulatory audit support. Provide trouble shooting, root cause analysis serving as scientific and technical expert on issues that affect AVI. Provide technical support on CMOs Visual Inspection program. Conduct assessments to multiple sites Visual Inspection Program Co-Represent Pfizer on multi-pharmaceutical industry SMEs network (BioPhorum) -
GIANMARCO PINCELLI
Technical Sales Manager, Bonfiglioli Engineering srl
Presenter
Read BioGIANMARCO PINCELLI
Bonfiglioli Engineering srl
Gianmarco Pincelli is currently in charge as Technical Sales Manager at Bonfiglioli Engineering, which is part of TASITEST Group. He received its degree in Mechanical and Specialization on Machinery Technical Documentation in Ferrara (Italy) in 1998, and after some work experiences as a freelance for different Mechanical Design Offices, in 1999 he joined Bonfiglioli Engineering. Devoting his professional life, at the beginning as Mechanical Designer Pharma Specialist and shifted progressively to Pharmaceutical Application Team Leader and to Design Team Manager in 2010 till 2019. Now he moved to the Sales, being responsible for Sales Network & worldwide agencies technical training, and giving assistance in customized projects; he also represents BE company at PDA events as well as other congresses and exhibitions. -
Andrea Sardella, PhD
Moderator
Panelist
Read BioAndrea Sardella, PhD
Andrea Sardella holds a degree in Physics from Padua University and a Master's in Nuclear Engineering. As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garching IPP (DE). After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial applications as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools. He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for inspection machines. Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group. -
Menno Sels, MSE
Project Engineer VI & CCIT, eyetec
Co-Presenter
Read BioMenno Sels, MSE
eyetec
Graduated Chemical Engineer involved in several GMP projects in the past 5 years. First hand experience in managing Visual Inspection projects from A to Z. Determined problem-solver and analytical thinker. -
John G Shabushnig, PhD
Principal Consultant, Insight Pharma Consulting, LLC
Moderator
Panelist
Presenter
Read BioJohn G Shabushnig, PhD
Insight Pharma Consulting, LLC
John is the founder of Insight Pharma Consulting, providing expert guidance in visual inspection and particle control. He began his career with The Upjohn Company responsible for process analytical technology (PAT) and visual inspection. He was Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation. He later served as Director of the Center for Advanced Sterile Technology. Before starting his consulting firm, he managed microbiology and aseptic manufacturing technical support for Pfizer’s Global Quality Operations. John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the Parenteral Drug Association, having served as chair of the Board of Directors and chair of the Science Advisory Board. He organized and co-leads the Visual Inspection Interest Group. He also instructs at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on spectroscopic analysis, PAT, rapid microbiological testing and visual inspection of pharmaceutical products. He co-authored the recently published book Visual Inspection and Particulate Control. -
Mitsutaka Shirasaki
Principal Engineer, Genentech Inc.
Presenter
Read BioMitsutaka Shirasaki
Genentech Inc.
Mitsutaka Shirasaki is a Principal Engineer at Genentech/Roche with 24 years of experience in the visual inspection field. His career started with Eisai Machinery (currently Syntegon Pharmaceutical Technology) as a field service Engineer and worked with many companies in the industry for qualification of AVI equipment. He is a member of the BioPhorum VI workstream and published multiple industry guidance papers along with other esteemed authors. He is passionate about advancing the VI technologies and developing more effective methods of AVI qualification. -
Tracey Sinjen
Principal Consultant, Lachman Consultants
Co-Presenter
Presenter
Read BioTracey Sinjen
Lachman Consultants
tbd -
Brian Turnquist, PhD
Chief Technical Officer, Boon Logic
Presenter
Read BioBrian Turnquist, PhD
Boon Logic
Brian Turnquist is Chief Technical Officer of Boon Logic, an AI software company in Minneapolis specializing in applying unsupervised machine learning in regulated industries and mission critical applications. Turnquist received his PhD in mathematics from the University of Maryland in 1997 and spent most of his career in neuroscience developing techniques for automated classification of neural activity, with full-time positions at Johns Hopkins University, Bethel University, and visiting research appointments at the Universities of Nürnberg and Heidelberg. At Boon Logic, Turnquist has applied these techniques to computer vision-based anomaly detection, leading to the development of novel, AI-based technologies for visual inspection of parenterals. -
Romain Veillon
Director Vision Technology, GSK
Co-Chair
Moderator
Panelist
Presenter
Read BioRomain Veillon
GSK
Already done -
Bill Waterstreet
Principal Validation Engineer, Performance Validation
Co-Presenter
Read BioBill Waterstreet
Performance Validation
Bill has supported cGMP compliance projects for the pharmaceutical industry since 2015. Has experience in the development of validation documentation and specifications for equipment including the associated control systems. Has also supported building commissioning for both new construction and building renovations. Experience includes facilities, clean utilities, dirty utilities, HVACR, and inspection equipment. -
Rick J. Watson, BS Chem Eng
Director, Merck
Co-Chair
Moderator
Panelist
Presenter
Read BioRick J. Watson, BS Chem Eng
Merck
Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 28 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past twenty years at Merck focusing on the visual inspection processes for parenteral products. During this period, he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and glass breakage management for Merck manufacturing sites around the world. -
David B Wetherington
Sr. Manager, Operations (Visual Inspection and Packaging), Thermo Fisher Scientific
Presenter
Read BioDavid B Wetherington
Thermo Fisher Scientific
Blaine Wetherington Senior Manager of Operations (inspection and Packaging) at Patheon, a part of Thermo Fisher Scientific) 17 years of pharmaceutical industry experience spanning multiple roles and responsibilities including industrial engineering, continuous improvement and operations. -
Linda Wildling, PhD
Head of Digital Innovation Success Management, Takeda Pharmaceuticals International AG
Moderator
Panelist
Read BioLinda Wildling, PhD
Takeda Pharmaceuticals International AG
Linda Wildling did her Ph.D. and Post-Doc research at the Institute for Biophysics at the University of Linz in Cell Communication in the Health and Disease field. In 2011 she joined Takeda Pharmaceuticals and worked in several positions within Takeda Site Quality and Production. She has broad experience in Pharmaceutical development, Auditing, Regulatory & CMC, and Contract Manufacturing management, including sterile production and lyophilized products. Linda works in Digital within Takeda Manufacturing as Head of Digital Innovation Success Management. To drive digital innovation, she is also leading the project AI-enabled, automated inspection of lyophilized products in sterile pharmaceutical manufacturing. She is the Co-Lead of Takeda´s Global Visual Inspection Program - Visual Inspection in Parenterals and Particles Management.
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