Dr. Alison Armstrong
Senior Director and Global Head of the Technical and Scientific Solutions at Merck- ICH Q5A Revision: Quality Control Through Viral Contamination Risk Mitigation for Monoclonal Antibodies Drugs, Gene Therapies and Beyond
- Panel Discussion and Q&A
Dr. Alison Armstrong is Senior Director and Global Head of the Technical and Scientific Solutions team. She established a client facing scientific consultancy team in 2015. This team is responsible for scientific and regulatory advice and fully supports customers worldwide. Dr. Armstrong has authored a number of articles on trends in biosafety testing and is a member of regulatory taskforce groups related to rapid technologies. She is an invited speaker at global conferences.
Dr. Armstrong holds a PhD in Molecular Virology from the University of Glasgow
Bettine Boltres
Director Scientific Affairs & Technical Solutions, Glass Systems of West Pharmaceutical Services- Updates on TR 73-2, Medical Device Regulation , General Safety and Performance Requirement for Prefill 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.
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.
Arthur Dumba
Director and General Manager of The Society for Sterility Assurance Professionals (SfSAP)- Knowledge, Skills, and Experiences: Competencies for a Sterility Assurance Professional
- Panel Discussion and Q&A
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.
Marc Glogovsky
Business Unit Manager at Valsource Inc- Moving Forward on Direction to Continuous and Real-Time Environmental Monitoring for Aseptic Filling
- Panel Discussion and Q&A
Marc Glogovsky is currently a senior consultant and manager of the microbiology division with ValSource, Inc. In his current role, he is focusing on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.
Marc has been an active PDA member since 2000 and is currently serving on both the Science and ATMP Advisory Boards and as co-chair of the Microbiology/EM Interest Group. He has co-chaired and contributed to several Technical Reports and Points to Consider documents.
Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology & Molecular Genetics from Rutgers University.
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.
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.
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.
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).
Ivy Louis
Founder of Vienni Training and Consulting- PDA ANSI Standard Approach to Quality Risk Management in Aseptic Processing
- 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.
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.
Peter Qiu
External Advocacy Lead China at Roche Genentech- Quality Maturity Model / Quality Improvement & Learning From Recent Inspections
- Panel Discussion and Q&A
Dr. Peter Qiu is the External Advocacy Lead China at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.
Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.
Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.
James Vesper (Virtual)
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.