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Brooke Higgins
Senior Policy Advisor for the Global Compliance Branch 3, CDER at US FDABrooke K. Higgins is an Acting Branch Chief and Senior Policy Advisor for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance (CDER/FDA). In this role, Ms. Higgins oversees the review of domestic and international pharmaceutical cases and handling of associated regulatory actions. Ms. Higgins has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, she spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, Ms. Higgins continued performing drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate in 2009, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.
Bernard Marasa
Pharmaceutical Scientist, Center for Drug Evaluation and Research at Food and Drug Administration- FDA Perspective on Pre-Approval Inspections, Common Findings and Factors Leading to Success
- Q&A Session
Dr. Marasa is a Pharmaceutical Scientist within the Division of Microbiology Assessment-II in the Office of Process and Manufacturing Assessment in CDER/FDA. He is a subject matter expert in the evaluation of the quality of manufactured and compounded sterile drug products, and microbiological hazards posed by manufacturing facilities, processes, and equipment in supporting regulatory submissions. He was previously a Senior Research Associate at Catholic University of America-D.C and held a three-year post-doctoral fellowship at the National Institute of Health. He holds a Ph.D. In Medical Pathology from University of Maryland, Baltimore, an M.Sc. in Molecular Biology from Vrije Universiteit Brussels-Belgium, and a B. Sc (Biochemistry) from Jomo-Kenyatta University-Kenya. He has won several awards including 2023 CDER Incentive Award, 2015 NCTR Research Excellence Award and Bill & Melinda Gates Grand Challenge Exploration Award and has authored over 40 research publications.
Yeonhae Han
Deputy Director of the Biopharmaceutical Quality Management Division at Ministry of Food and Drug Safety (MFDS)Yeonhae Han is Deputy Director of the Biopharmaceutical Quality Management Division of the Ministry of Food and Drug Safety (MFDS), Korea. She is in charge of pre-approval GMP inspection of vaccines, recombinent proteins and plasma-derived products. She has over 15 years pharmaceuticals regulatory experience.
She holds a bachelor's degree in pharmacy from Seoul National University.
Arthur Dumba
Director and General Manager of The Society for Sterility Assurance Professionals (SfSAP)Arthur Dumba is a Radiation Sterilization consultant and has been supporting various healthcare companies across Europe and the USA in gamma, electron beam and X-ray processing, and dosimetry. Arthur is an initial founder of the Society for Sterility Assurance Professionals (SfSAP), and with the support of the International Irradiation Association (iia), AAMI, ASTM and PDA. SfSAP is leading the initiative to provide a competency framework and career development pathway for those involved in the field of sterility assurance. Arthur has over 25 years of healthcare industry knowledge and over 15 Years Irradiation and Sterilization experience and knowledge. He is a member of ASTM E61 on Radiation Processing and an IIA contributor member.
James Vesper
Director of ValSourceJames Vesper, PhD, MPH designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries and is Director, of Learning Solutions at ValSource, Inc. He has had more than 40 years experience in the pharmaceutical industry.
Dr. Vesper has written six books, including Root Cause Investigations for CAPA (2020) and multiple technical articles on risk management. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author/Editor of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has trained health authority inspectors through WHO and PIC/S in US, Taiwan, London, China, Greece, Turkey and Brazil.
Bettine Boltres
Director Scientific Affairs & Technical Solutions, Glass Systems of West Pharmaceutical Services- Updates on Technical Report No. 73-2: Application of Medical Device Regulations, Annex I Requirements (GSPRs) for Staked Needle Syringes
- Panel Discussion and Q&A
As Director Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Bettine is an active member of the USP Packaging and Distribution Expert Committee, the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). She is Convenor of the ISO Working Group 4 (Elastomers) and member of the Working Group 2 (glass). Additionally, Bettine is on the PDA Board of Directors and in 2015, she published the book “When Glass Meets Pharma”, which builds the bridge between glass for pharmaceutical primary packaging and drug substances. Dr. Boltres is a (bio)chemist by training, receiving a diploma in chemistry from the University of Frankfurt, Germany and a PhD in biochemistry from the university of Cologne, Germany.
Susanne Hall
Director, Secondary Packaging & AVI Projects of VETTER PHARMASusanne Hall began her career in 1990 at Dr. Karl Thomae in Biberach as Head of Packaging Technology. In 1993, she joined Vetter’s Research and Development department as Head of Packaging Material Incoming Control and in 2008 was named Team Leader of Secondary Packaging. Since 2019, she has been the Director of Secondary Packaging and AVI Projects. In this position, Susanne leads three teams that ensure the implementation of customer products from development to commercial into production. For secondary packaging this includes device assembly, labeling and final packaging as well as implementing tests for a controlled safe process and the meeting of customer expectations. She is also responsible for the transfer of products from manual visual inspection to fully automated inspection lines. Susanne has a diploma in engineering from the College of Engineering where she focused on specialized precision engineering.
Hussein Bachir
Senior Scientist, GMP Compliance at Franz Ziel GmbHHussein Bachir has made substantial contributions to academic research in the field of neuroimmunology and nephrology, discovering new insights and developing approaches to treating diseases. These novel insights led to several publications in renowned journals in both research areas. In 2021, his research was awarded by the German Society for Nephrology. In April 2023, his expertise culminated in a PhD in Molecular Nephrology at the University Hospital of Münster, Germany. He recently joined Franz Ziel GmbH and looks forward to meeting their customer requirements in GMP Compliance to enhance healthcare through technology.
Amanda Bishop-McFarland
Senior QRM and Microbiology Consultant at ValSource- PDA’s Proposed ANSI Standard QRM (Tool) for Aseptic Processing:An Overview of What Is in the Works
- Panel Discussion and Q&A
Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and a member of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida.
Javier Camposano
Chief Operating Officer at LiferaJavier Camposano serves as the Chief Operations Officer- at Lifera, Saudi Arabia and is also a member of the PDA Board of Directors and past chair of the APAC PDA. As COO, Javier is tasked with executing Lifera's overall vision to become the leading Biopharmaceutical company in the MENA region by implementing strategies to develop the local pharma sector and building state-of-the-art manufacturing facilities to supply lifesaving medicinal products to patients in need.
Prior to Lifera, Javier was the Head of the Global Drug Product Expansion Division at Celltrion Inc. directing the design and implementation of DP operations in South Korea. He also co-led Celltrion's Drug Product Division for Biosimilar products attaining US FDA and EMA approvals of the first mAbs in 2016 and 2013 respectively. Mr. Camposano started his pharmaceutical career at Baxter working in a variety of Fill and Finish Engineering and Management positions leading Aseptic Filling CAPEXs, technology transfers, commercial development projects and supervising cross functional functions.
He holds a BS in Mechanical Engineering from the University of California at Davis and an MBA from Pepperdine University - California.
Bobby Crawford
Director, Business Development of Quality Executive PartnersBobby started with Quality Executive Partners as a consultant before transitioning to the Virtuosi team as Director, Business Development and is responsible for business development globally. Bobby has over 30 years of pharmaceutical experience in operations, engineering, project management and sales/customer service leadership. His expertise in manufacturing, strategic planning, financial modeling, and Lean/Six Sigma principles enhances his ability to identify opportunities and cultivate client relationships. Bobby holds a Master of Industrial Engineering degree and an MBA from the University of Missouri, Columbia.
Michael Cutter
Chief Quality Officer at Biocon Biologics ltdMichael is a highly experienced Quality professional having spent more than 30 years in the pharma and biotech industry. He is currently the Chief Quality Officer at Biocon Biologics Limited and prior to that was head of Connected Health and Head of Pharma Quality at Merck KGaA before which he spent 5 years at Novartis remediation Warning Letters and launching new products. Michael has extensive global experience and has lead capacity building projects with the WHO in India and the European Union in the ASEAN region.
Richard Denk
Senior Consultant Aseptic Processing & Containment at Skan AGRichard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.
Michael Earl
Director of Pharmaceutical Services at Owen Mumford- Bringing an Innovative Auto-injector to Market Through Industry Collaboration
- Panel Discussion and Q&A
Michael Earl joined Owen Mumford as Director of Pharmaceutical Services in November 2020. He was previously the Commercial VP at Bespak, leading the commercial team there to drive growth in their substantial medical devices business. Prior to that, he worked for a number of pharma, biotech and device companies. In a career spanning more than 35 years, he has been responsible for all aspects and stages of drug and device development and commercialisation. Michael has also completed a substantial number of commercial, licensing and M&A transactions.”
Max Fernandez
Vice President at Intellective BioDr. Max Fernandez is a regulatory, quality and compliance professional with over 20 years of experience and global leadership in biologics development, regulatory strategy, CMC, quality and compliance, manufacturing and tech transfer covering preclinical to commercial product lifecycle management.
Dr. Fernandez has been based in California for most of his career, making significant contributions to Baxter’s global efforts in the recombinant and plasma products space, and culminating in the US FDA licensure of VONVENDI, the first and only recombinant protein therapy for von Willebrand disease, in 2015. Before coming to China, he was the Head of Global Regulatory Affairs at Samsung Biologics in Korea, where he helped international and domestic clients obtain more than 100 approvals from major health authorities (US FDA, EMA, PMDA, Health Canada, ANVISA, Cofepris, etc.) for over 40 commercial products in 3 years. This remarkable success rate was enabled by over 20 on-site regulatory inspections with no critical observations. As Vice President of Intellective Bio, Dr. Fernandez is committed to helping one of China’s fastest-growing CDMOs meet global standards and making accessible advanced therapies for all.
Dr. Fernandez received his PhD in Analytical Chemistry from the University of California.
Gilbert Fluetsch
Senior Director, Automation Systems of SHL MedicalGilbert Fluetsch is a highly experienced professional in the field of automation and operations. Since joining SHL Medical in 2016, Gilbert has led a team of automation experts in deploying cutting-edge solutions across SHL’s extensive autoinjector portfolio, standardizing existing equipment strategies and overseeing the development of new, high-speed assembly and testing machinery. Gilbert boasts over 30 years of experience in engineering, operations, and sales management within the medical device and semiconductor sectors. Gilbert holds an MBA in High Technology Management from the University of Phoenix and a BS in Business Administration from California State University San Marcos.
Marc Glogovsky
Business Unit Manager - Microbiology Consulting at Valsource Inc- Improvements and Implementation of a Continuous Environmental Monitoring Program
- Panel Discussion and Q&A
Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 25 years in the pharmaceutical industry, in various microbiology and management roles. In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.
He has been an active PDA member for over 20 years and is presently serving on the Board of Directors, both the Science and ATMP Advisory Boards and is the co-chair of the Microbiology/EM Interest Group. Marc is also co-chairing the Microbial Data Deviation Investigations workshop and participating on the planning committees for both the PDA/FDA and PDA Global Microbiology conferences. Additionally, Marc has chaired several Technical Reports and Points to Consider publications.
In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA’s Training and Research Institute, and the 2023 Michael Korczynski Award for his support of PDA’s international activities.
Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology & Molecular Genetics from Rutgers University.
Matthias Hiddemann
Technical Product Manager at Wilco AGMatthias got a mechanical diploma degree at the University of Dortmund (Germany) and a diploma degree in economics at the University of Bochum (Germany).
He started his industry career as a project manager within the plant engineering and construction industry. Throughout his career he gained more than 20 years of experience in sales, marketing, and product management withing the machinery industry in regulated environments.
Since 2021, Matthias is with WILCO – in his current position he is the Technical Product Manager with a focus on Container Closure Integrity Testing (CCIT).
Heonho Jung
Associate Director of Novartis Korea- Korea's ATMP Regulation’s Requirements, Scope, and Characteristics: How Are They Different from the EU and US?
- Panel Discussion and Q&A
Heonho Jung is an associate director in Global Cell Therapy Operations department at Novartis, Seoul, Korea. He had diverse experience from several quality roles, Microbiology analyst/QC analyst/Site CSV coordinator/QA manager/Certified QA Auditor/Quality Head of Korea local operating Company, during working for several multinational pharmaceutical companies, MSD/ Novartis V&D/Johnson and Johnson/GSK CH, for 20 years.
With GMP experiences, he also had a unique role as a biosafety officer at Institute of Pasteur Korea managing BSL 2/3 labs and QMS of Biosafety. Recently he has a role to perform on-boarding activities and continuously overseeing CAR-T cell therapy processes for the first approved CAR-T product’s sites in Korea after 2021.
Heonho Jung has a master’s degree in microbiology from Pusan National University and a bachelor degree in Chemical Engineering.
Steven Kaufman
Vice President, Drug Delivery Systems at Stevanato Group S.p.A.- Bringing an Innovative Auto-injector to Market Through Industry Collaboration
- Panel Discussion and Q&A
Steven has been with Stevanato Group for 5 years leading customer engagement while driving strategy related to proprietary product management and contract manufacture of device. He has 18 years of experience working with biopharma clients in the area of devices, including auto injector, pen injector, wearables, safety systems and inhalers. Comprehensive knowledge of device manufacturing, final assembly of device as well as testing, sub assembly and final assembly equipment for device. Responsible for deal structure, contracts and pricing.
Hyun Cheol (Charles) Kim
Vice President and Head of Plant, Pyeongtaek Bio Plant at Hanmi Pharm. Co., Ltd.Hyun Cheol (Charles) Kim has over 25 years of experience in the field of quality and manufacturing operation for both biopharmaceuticals and synthetic pharmaceuticals. He has extensive experience in operating QMS to produce clinical and commercial pharmaceuticals through his involvement in new drug development processes at LG Life Sciences (now LG Chem.) and Hanmi Pharm. He participated in the construction process of a new plant and set up the GMP operating system and through this, gained a deep understanding of GMP operation for plant facilities and utilities. He serves as an instructor in QMS and GMP operation training programs and advisory group at the Ministry of Food and Drug Safety (MFDS) and Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) to share industry opinions and experiences.
Jinwoo Kim
Compliance Manager at Samsung BioepisJinwoo Kim has over 20 years’ hands-on industrial experience in the Biotech and Pharmaceutical industry, focusing on qualification/validation, quality assurance for drug products, and regulatory compliance. He is currently part of the external / internal audit and GxP regulatory compliance monitoring/improvement at Samsung Bioepis’ Quality Team.
Hue Kwon
VP, Head of Quality at Samsung Bioepis- Session I - Opening Session-Regulatory Agency Perspective
- Q&A Session
- Session V - Human Error Reduction and Quality Improvement in Aseptic Environment, Part I
- Panel Discussion and Q&A
Dr. Hue Kwon has been serving as a Vice President and Quality Team Leader at Samsung Bioepis since April 2020. She leads a global quality team providing GxP quality and compliance oversight for the end -to-end drug development and lifecycle.
Prior to joining Samsung Bioepis, she served as Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus.
She also served as a senior advisor consultant in regulatory strategies for multiple organizations and global matrix environment and for digital health strategy, global IT and global operational alignment project in drug development.
Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.
MinYoung Kwon
Engineer, Manufacturing Science and Technology (MSAT) at Janssen Vaccines- Janssen Vaccine: A Case Study on Visual Inspection Improvement based on FDA’s Draft Guidance
- Panel Discussion and Q&A
Michelle has been with Janssen Vaccines and excels in the visual inspection field to play important pillar in securing FDA approval. As an Engineer in Manufacturing Science and Technology, she participates in visual inspection global Center of Practice (CoP) and work in collaboration with cross-functional engineering group to optimize process to achieve global harmonization and standardization.
Wayne Lee
Fast Trak™ Validation Services Leader, Global at CytivaWayne has more than 23 years of combined experience in the pharmaceutical and biopharmaceutical, R&D, and manufacturing industry. He has broad experience in pharmaceutical synthetic chemistry unit operations, as well as biologics downstream processing.
He is currently the Global GM for Fast-TrakTM Validation Services, for Cytiva. Prior to his current role, he has spent more than 13 years in Pall Biotech; in roles of increasing responsibilities. His previous tenure includes Global Head of Validation and Laboratory Operations; Head of APAC (+China) technical support (MS&T); and BioProcess (MS&T) leader for ASEAN. Earlier, he has mixed experience from the Singapore Polytechnic, Merck Sharp & Dohme (Global Technical Operations); Galileo Pharmaceuticals and the Port of Singapore.
He was one of the founding board members of the PDA Singapore Chapter; current board member of the Singapore Chapter, previous board member of the UK Chapter and life-member of the Singapore National Institute of Chemistry (SNIC).
He is a seasoned practitioner of multiple Danaher Business system (DBS) tools; fluent in PSP, DM, SLXII, and is working towards Certified Practitioner (CP) for TPI, and is CP for VS 2.0. He holds a Ph.D. (Organic Chemistry; National University of Singapore) and an M.B.A. (Strategic and Operations Management; University of Bradford); and Double Bachelor’s Degree (Honors and Merit; Chemistry; National University of Singapore).
Noel Long
Senior Sterility Assurance Adviser at Cytiva- PDA’s Proposed ANSI Standard QRM (Tool) for Aseptic Processing:An Overview of What Is in the Works
- Panel Discussion and Q&A
Noel Long is a Contamination Control and Sterility Assurance Professional with in-depth understanding of global regulatory requirements across pharmaceutical, biopharmaceutical, medical device and healthcare industries. Noel’s experience has focused on aseptic drug product manufacturing and contamination control and reaches across API, cell banking, cell culture, purification, formulation, filtration, aseptic filling, lyophilization, and drug product inspection activities. In her career which includes validation, manufacturing, and quality roles, she has championed and implemented the practical application of microbiology and engineering principles to support filling line design and operation, cleanroom management, quality risk management, sterilization processes, and lifecycle management. Noel has held positions of increasing responsibility at Wyeth, GSK, Morphotek (acquired by Eisai), Alexion Pharmaceuticals (Acquired by Astra-Zeneca), GE Healthcare and Cytiva (A Danaher Company). In her current role Noel is a recognized technical expert and leader, ensuring compliance and enabling agility while supporting projects such as Annex 1 alignment, cleanroom design, contamination remediation, complex investigations, particulate monitoring and control, visual inspection, container closure integrity, cleaning and disinfection, environmental monitoring, bioburden control, aseptic processing, and sterilization (moist heat, depyrogenation, ethylene oxide and irradiation).
Michael Lopez
President and CEO of HSL BioTechnologies IncMichael Lopez is currently the President and CEO of HSL BioTechnologies. Prior to this, he was a Senior Vice-President at Medytox Inc., Korea where he was responsible for Global projects and strategic leadership of Quality functions and systems, including clinical and commercial manufacturing for US, EU and Asian markets. As a member of the Medytox Executive Team, he was actively involved in promoting and providing cGMP and EU GMP training and SME development for his biopharma employees in Korea.
Paul Lopolito
Senior Manager, Technical Services at STERISPaul Lopolito is a Senior Manager, Technical Services for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to process cleaning, cleaning validation, and contamination control, which includes field support, site audits, training presentations, and educational seminars. Paul has over 25 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager.
Ivy Louis
Founder of VIENNI® TRAINING & CONSULTING LLP- PDA’s Proposed ANSI Standard QRM (Tool) for Aseptic Processing:An Overview of What Is in the Works
- Panel Discussion and Q&A
Ivy Louis is the Founder of VIENNI® TRAINING & CONSULTING LLP, holds a Master's degree in Pharmaceutical Sciences and an MBA in Human Resource Management.
Ivy's combined 33 years spanning across teaching, pharmaceutical manufacturing/quality, and service provider experience is distilled into the consultative and educational approaches that her organization-VIENNI Training & Consulting LLP has been delivering from 2010 onwards. The areas of support for pharmaceutical and biopharmaceutical operations rests on building excellence through consulting in parenteral operations and catering to the learning requirements for operating personnel through training & education.
Ivy has been associated with PDA Inc.(www.pda.org) from 2003, as a member. She has been extremely active in spearheading the activities of the Parenteral Drug Association Chapter in India, from 2013 onwards. Ivy has been contributing in the various capacities as a PDA India Chapter Board member between 2013-2019. She has also been a Member of the Steering Committee for Awards in 2017, Member of the Steering Committee for the PDA letter Editorial Committee and a member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing. She is also a member of the Science Advisory Board for PDA Inc.
Deok Seok Oh
Head of QA at Janssen VaccinesDeokSeok is a Head of QA (NPI and Commercial) at Janssen Vaccines Incheon site and responsible for overall New Product Introduction (NPI) and commercial product manufacturing. His background comes from more than 17 years of industry experience in GMP manufacturing, MSAT and Quality. DeokSeok has served as a SME in aseptic area for many years and has a diverse experience in project management which includes plant construction, new-line project, NPI, and tech transfer activities. DeokSeok also has extensive regulatory inspection experience including recent successful US FDA inspection as well as UK (MHRA), EU, WHO, and MFDS inspections. DeokSeok holds a Bachelor's degree in Biological Science from Seoul National University and member of local & global communities (VP of PDA Korea chapter). DeokSeok is also involved in many pharmaceutical training program (K-NIBRT).
Seung Hwan Oh
Site Quality Head, Quality at JanssenSeungHwan Oh is a highly accomplished professional with 21+ years of experience in biopharmaceutical/vaccines parenteral products. He has extensive knowledge and experience in process development, equipment qualification, quality management, process validation, lean manufacturing, process quality improvement, technology transfer, life cycle management, and project management. SeungHwan has demonstrated highly sophisticated project management skills and strategies through multiple successful projects. He is experienced in diverse multicultural working environments in Netherlands and Vietnam. SeungHwan is currently the Site Quality Head at Janssen Vaccines Corp. Incheon and holds a Master's degree in Biochemical Engineering from HanYang University, Seoul, Korea.
Sea Joung Park
Head of Sales at DatwylerSea Joung Park('SJ') is the Head of Sales, South Korea at Datwyler Healthcare since June 2023, responsible to cultivate new business opportunities in this market. With a remarkable 32-year career in the medical device industry, he brings a wealth of experience to the table.
SJ spent 20 years in various roles with PFS products at Becton Dickinson. In the last 7 years, he shifted gears to the consumer diabetes business. His academic credentials include a bachelor's degree in Industrial Engineering and a master's degree in Marketing, both earned at Sungkyungkwan University.
Based in Seoul, SJ is well-equipped to continue his legacy of driving business growth and fostering invaluable relationships in the pharmaceutical industry for Datwyler.
Gabriele Peron
Senior Marketing Advisor at Stevanato Group S.p.A.Mr. Peron has been in the field of marketing services for 20 years, with experience in web applications and advanced interactive technologies for pharmaceutical companies.
After holding the role of Marketing & Communication Manager for several years, in charge of coordination and execution of all marketing activities, he is currently Senior Marketing Advisor at Stevanato Group.
Morgan Polen
Contamination Control Expert at MicroriteMorgan Polen is a subject matter expert on contamination control, airflow visualization, and particle monitoring in cleanrooms with over 35 years of industry experience.
He is a member of the ISO Technical Committee 209 (Cleanrooms and Associated Controlled Environments) and a board member of IEST and has been instrumental in drafting and editing international cleanroom standards and best practices. He has extensive experience in working on cleanroom projects in the United States, Canada, Mexico, Germany, Malaysia, Taiwan, South Korea, Singapore, Thailand, China, Philippines, India, and Turkey and is a valuable resource in addressing contamination control in critical environments for the electronics, aerospace and healthcare industries.
As a key member of Microrite’s Expert Contamination Control team, Morgan is instrumental in the development of proactive contamination control strategies through pragmatic risk assessment, troubleshooting contamination issues, and helping with FDA 483/warning letter remediation activities.
Mohammad Rashedi
Data Scientist at Amgen- Application of Machine Learning Algorithms for the Monitoring and Control of Cell Culture Processes
- Panel Discussion and Q&A
Mohammad Rashedi holds a bachelor's and master's degree in mechanical engineering from Sharifi University of Technology and earned his PhD in process control from the University of Alberta. He commenced his career at Amgen in 2020 as a senior engineer and, in 2022, was promoted to the role of data scientist. His area of specialization lies in hybrid modeling, monitoring, and control of cell culture processes. Through the application of model predictive controllers, he has successfully optimized feeding strategies for these processes, resulting in significant increases in productivity.
Christine Roberts
Senior Standards Manager at Parenteral Drug Association- PDA’s Proposed ANSI Standard QRM (Tool) for Aseptic Processing:An Overview of What Is in the Works
- Panel Discussion and Q&A
Christine joined the Parenteral Drug Association (PDA) as their Senior Standards Manager in 2017. Prior to this, she was affiliated with the American Type Culture Collection where over 16 years, she served in numerous capacities to include technical services, a cell biology lab, and as a standards and certification specialist. She served for 13 years in clinical transplant in the histocompatibility lab at the Medical College of Virginia in Richmond, Virginia, Sentara Norfolk General Hospital in Norfolk, Virginia. She also worked as a Senior Donor Services Coordinator for the “Be The Match” program operated by the National Marrow Donor Program/ CW Bill Young Marrow program in the Washington DC area. She earned her degree from Virginia Tech.
Carina Van Eester
Global Platform Leader of Prefilled Syringes and Cartridges at DatwylerCarina Van Eester graduated as an industrial engineer in chemistry and started her career in the pharma industry. After 15 years of experience as a packaging development engineer of parenteral packaging and project manager, she moved to Datwyler. She has now been with Datwyler for 16 years; she spent 7 years as a Technical Key Account Manager, providing technical support to customers, and 4 years as a Global Qualification and Validation Manager, working to set-up the Datwyler validation approach. She also gained a lot of experience in sterilization technologies like gamma irradiation and steam sterilization while working at pharma companies and within Datwyler. She moved into the role of Global Platform Leader for Prefilled Syringes and Cartridges in 2018, making sure that the standard portfolio of the rubber components used for these packaging presentations secures Datwyler’s position as a market expert for PFS and cartridge sealing solutions.
Lyndon Wild
Global Head, Project and Program Management at SHL Medical AG- Technology Demo by SHL Medical: Modularization of Assembly and Testing Equipment Platforms for Medical Device Packaging
- Key Sterilization and Manufacturing Considerations for Cartridge-based Autoinjector Systems
- Panel Discussion and Q&A
As Global Head of SHL Medical’s Project and Program Management, Lyndon oversees the successful execution of complex drug delivery device projects across SHL’s global sites. Through strategic vision, effective collaboration, and results-driven management, Lyndon leads his team in ensuring seamless coordination, on-time delivery, and optimal resource utilization for each customer project.
Lyndon joined SHL in 2016 and has since contributed to both the manufacturing and commercial aspects of SHL’s operations. He brings over 20 years of professional experience in Director-level roles within pharmaceutical, medical devices, and medical packaging industries.