Subrata Chakraborty, MS Pharma
GxPFONT Consulting Group
Subrata Chakraborty is a Pharmaceutical professional having over 24yrs of experience handling Manufacturing operations, Quality assurance, Validations, cGMP-compliance, Training and Project management.
Apart from being an SME of Aseptic Processing and Validations, Subrata played important roles in people and organization development in his past industry tenures, which included over ten years of senior leadership roles in global MNCs like Cipla, Pfizer, Novartis and Fresenius-Kabi.
Subrata is currently leading GxPFONT Consulting group, a global Pharma Consulting and Technology solutions company, as Principal Advisor.
- He is an active member of PDA and ISPE, and currently volunteers as “PDA-letter editorial committee” from Asia-pacific region.
- He is a member of the working group of Society for Sterility Assurance Professionals, a UK based not-for-profit standard setting organization.
- He is a member of “PDA TR-22 (Aseptic Process Simulations) revision team”.
- He is the reviewer for many technical publications including;
- PDA PtC for Isolator Technology,
- PDA TR on Technology Transfer, and
- WHO guidance on Technology Transfer (as a member of PDA commenting Team).
He has authored/co-authored in several technical articles and journals related to Aseptic processing and Emerging technologies, and contributed in many industry wide forums for compliance and productivity improvement.
Roy T. Cherris
Bridge Associates International & InQuest Science LLC
Roy T. Cherris has over 40 years of process and QA experience in microbiology, microscopy and inspection. He is a founding member and Managing Partner of Bridge Associates International consultancy in Princeton, NJ. He is also Chief Science Officer of InQuest Science providing training and guidance on particulate matter and physical defect control, optimized inspection and expert defect life-cycle tracking systems.
Roy has studied forensic microscopy extensively at the McCrone Research Institute in Chicago.
He is a respected SME in the field of visual inspection systems and investigative microscopy for particle or defect source identification and mitigation. Roy served as the chair of the PDA task force for evaluating particulate matter in Difficult to Inspect Parenteral products which developed PDA TR-79 and he is an active member of the USP Expert Panel for Visual Inspection of parenterals which produced USP-790 and USP-1790.
Rukman S. De Silva, PhD
Rukman De Silva, Ph.D. is currently working as a Chemist/Product Quality Reviewer in FDA/CDER/OBP/Division of Biotechnology Review and Research 4. 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 as a Staff Fellow in Dr. Gibbes Johnson’s lab. In addition to review, inspection, training and policy activities, he conducts research on studying the structure-function relationship of ErbB2 receptor at FDA. His research interest includes studying mechanisms of protein structure-function relationships and assessment of protein product quality attributes.
He is the co-organizer for the FDA Protein Aggregates Interest Group. He has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker in multiple conferences in the area of visible and subvisible particulates testing in past few years. He has published in peer reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also serves as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.
Massimo Frasson, MS
Brevetti C.E.A. Spa
After achieving a Master’s Degree in Mechanical Engineering, Mr. Frasson worked for several international companies in the automation industry.
He joined Brevetti C.E.A. in the year 2000 as Mechanic Systems Design Manager.
From 2004 he undertook the technical management of the company and later on in 2007 he began the restructuring of Brevetti C.E.A.’s production and the expansion of the entire range of products by introducing new vision’s technologies.
In the same period, he was coordinating and supervising a special department dedicated to the pharmaceutical process analysis through the development of artificial vision systems using also neural algorithms.
On 2010 he became responsible of the whole operations process and in February 2014 he has been appointed as the General Manager of Brevetti C.E.A. Company.
Florian joined Vitronic’s healthcare division in 2018. He is responsible for automated visual inspection solutions for pharmaceuticals and medical devices. The main focus of his work as a Product Manager is the identification of process requirements in difficult to inspect products and translating into new standardized solutions.
Before joining Vitronic Florian gained experience in medical device, hygiene and environmental technology industries. He holds an MBA and an engineering degree in Technical Health Care.
Ron Lawson, PMP
Mr. Lawson has spent the past 30 + years involved in the design, development, and life cycle management of automated inspection systems in the Pharmaceutical industry. For the past 5 years, Mr. Lawson has been the Director of Operations at Prime Results where they have developed innovative tools to simplify qualification tasks and to build in continuous improvement methods for automated inspection. Over the past 2 years, this has included inspection systems built on Deep Learning technology. Prior to Prime Results, Mr. Lawson was a founder of Seidenader Vision where, as it’s President, he led the development of the inspection stations on the industry’s first automated cosmetic inspection machine as well as the first automated LYO inspection machine. While with the Seidenader organization, Mr. Lawson was named Director of the Global Innovation Group who had the responsibility to research and analyze technologies that could prove useful in Pharmaceutical inspection applications.
Julie Mankey, MS
Julie Mankey is an experienced visual inspection subject matter expert for Pfizer with more than 10 years of experience in OSD, sterile injectable, and medical device. Julie’s areas of expertise are in manual inspection, qualification program development/enhancement, defect creation, particle control and monitoring, and defect trend analysis. Julie specializes in project implementation and compliance remediation.
Robert J. Miller, MS
Rob Miller has been with Pfizer Global Technology and Engineering, Sterile Inectables Technology as a subject matter expert and group leader in visual inspection since 2019. Prior to this he worked within Pfizer Global Quality supporting the sterile injectables network and responsible for internal policy associated with visual inspection. Prior to this role he worked as an automation/controls engineer and inspection process engineer for 22 years. He is responsible for supporting Pfizer’s aseptic network with internal guidance and policy related to manual and automated visual inspection. In addition, he reviews site inspection processes for compliance and directs strategic initiatives to the Pfizer network. Rob has a B.S. in Electrical Engineering, an M.S. in Engineering Management and a Graduate Certificate in Applied Statistics.
Giannina Re is a certified PMP® with a master's degree in Computer Science. She has 20+ years of experience in software development and pharma vision inspection projects. She started her career as a software engineer; in 2004 she joined Stevanato Group as a vision system development manager for the Group’s business unit specialized in visual inspection solutions. She focused on developing applications for the acquisition and processing of images and the machine user interface. In 2014 she was appointed Project Manager and is now responsible for organizing and deploying visual inspection machines manufacturing process from the URS definition till the factory acceptance tests.
David Sattlegger, Dr.
MVTec Software GmbH
David Sattlegger studied physics and mathematics at the Technical University of Munich. He obtained his doctorate in mathematics in 2015 for his work on numerical quantum dynamics. Since then, he has been working as research engineer at MVTec Software GmbH where his primary field of research is deep learning and artificial intelligence. His current focus lies on the development of unsupervised anomaly detection and segmentation methods for natural images and their application to industrial manufacturing processes. His research is published in computer vision conference proceedings and journals, and several of the resulting algorithms are already in use in industrial applications.
Christian A. Scherer
Körber Pharma Inspection (Seidenader)
Christian completed a technical apprenticeship at Seidenader Maschinenbau before visiting the University of Supplied Science in Munich.
He graduated in 2009 with a diploma in Business and Engineering before spending one semester in Seidenader's subsidiary SV Research in Harrisburg, USA and at the University of Plymouth, England.
From September 2009 to May 2015, Christian was Area Sales Manager at Seidenader Maschinenbau GmbH in the Business Unit Inspection Machines. Since May 2015, he has been Head of Sales with the responsibility for the sales department of the Seidenader Business Unit Inspection Machines.
Wolfram Schindler, PhD
Syntegon Technology GmbH
Dr. Wolfram Schindler is the Global Product Manager Inspection Technology at Syntegon (formerly known as Bosch Packaging), responsible for the portfolio of Visual Inspection and Container Closure Integrity Testing (CCIT). With a strong background in physics, he has been working in the field since 2014 when he took an expert position focusing on measurement systems for automated CCIT platforms. He contributed to a large range of development and customer projects related to the three major test methods headspace analysis, high voltage leak detection and vacuum decay, covering all phases from planning the first sample test to data analysis of the final validation batch.
John G. Shabushnig, PhD
Insight Pharma Consulting, LLC
John is the founder of Insight Pharma Consulting and is an expert in visual inspection. He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology.
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 PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board. He organized and leads the Visual Inspection Interest Group. He is also a trainer 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 presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods and visual inspection. He is a co-author of the recently published book Visual Inspection and Particulate Control.
Joseph A. Straub
Merck & Co., Inc.
Joseph Straub graduated from the Pennsylvania State University with a bachelor's degree in Engineering Science and Mechanics. Joe has 25 years of experience in the pharmaceutical and semiconductor industries, including the last 12 years at Merck focusing on the visual inspection processes for parenteral products. Currently, Joe works in global technical operations where he provides support for vision inspection processes and primary packaging components to Merck’s manufacturing sites and partners around the world.
Romain Veillon, PharmD
Romain Veillon is Senior Manager Visual Inspection & Leak Testing at GSK Vaccines, in Global MSAT Manufacturing Technologies. As global expert he is leading Visual Inspection performance and expertise network on multiple sites.
He now focuses on Quality Integration Lead, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement and Develop Equipment strategy within network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing in machine learning and innovation management with new AVI-LT asset deployment.
For the past 22 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, Eli Lilly and GSK Vaccines, in support to production and secondary operations projects for filling and freeze-drying.
He also developed innovative vision systems with some academic collaborations and regular presentation to PDA conferences.
In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain is Interest Group Leader for Visual Inspection in PDA Europe. Since 2019, Romain co-lead task force to prepare a point to consider document for AI applied to Visual Inspection. In 2020 Romain received PDA James P. Agalloco Award for educational training.
Rick J. Watson
Merck & Co., Inc.
Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 25 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 eighteen 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 primary packaging components for Merck manufacturing sites around the world.
Jeffrey Williams is a Manager in Drug Product Processing Engineering for Catalent Biologics and has nearly a decade worth of experience spanning R&D, validation, and manufacturing roles including more than 5 years in the pharmaceutical and medical device industry. Jeff is responsible for the primary and secondary process engineering technical teams at Catalent Biologics’ facility in Bloomington, Indiana. In particular, Jeff’s team focuses on implementation of automated visual inspection systems throughout the facility and vision recipe development. Jeff holds a B.S. in Mechanical Engineering and a M.S. In Mechanical Engineering from the University of Maryland, College Park.
Neal A. Zupec
Neal has over 30 years in the area of pharmaceutical products and medical device manufacturing for Baxter. He supports products through their lifecycle with focus on manufacturing operations and quality driven efforts specifically related to product and process controls with emphasis on particulate matter. This emphasis expands into the elements of cleanroom control and monitoring. Neal’s technical background stems from being located in the centralized research and development organization within the company responsible for the characterization of failure modes, identification of particulates and root cause analysis in support of product through its entire lifecycle. This perspective also provides for valuable inputs into external organizations for the shared understanding and development of guidance’s and standards.