Committee & Presenter Biographies

Susan is currently Director of Commercial Technology Development at West Pharmaceutical. Prior to joining West, Susan has held various technical, commercial and academic roles in the Healthcare industry with Datwyler, W.L. Gore and as an Adjunct Professor at Temple University.  She also serves as Vice Chair for the PDA Packaging Science Interest Group.  She holds a B.S. in Chemistry from the University of Rochester and a Ph.D. in Physical Chemistry from the University of Pennsylvania.

Dr. Mauro Giusti holds a Master Degree in Chemistry at University of Florence, he is board certified by the National Chemist Association and board certified as Technical Director (Qualified Person) by the Italian Minister of Health.

After serving as an army officer, he joined Eli Lilly Italy in 1988. He has covered several positions within the Lilly Manufacturing organization (Regulatory, Technical Services, Project Management, QC, QA, Operations, Technical Director/Qualified Person, Six Sigma Champion, Science and Technology, Procurement), dealing both with Lilly manufacturing plants as well as with Contract manufacturing in Europe, Africa, and Asia.

Among the several experiences with Lilly, he has worked in the USA from 1992 to 1994 and in the United Kingdom from 1997 to 1999. In September 2019 he took his current role, as Senior Director, Site External Network.

For more than 16 years he has served as a member of the Italy Chapter of PDA, with several participations to national and international forum both as speaker and as chairman. In November 2019 he has been appointed as Co- Chair for the Process Validation Interest Group. In August 2020 he has been appointed to the PDA Science Advisory Board (SAB). In December 2021 he has been appointed President, PDA Italy Chapter.

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 conference and participating on the planning committee for PDA/FDA and Global Microbiology conferences. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and is currently supporting multiple PDA global chapters.

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 work with PDA’s international chapters.

Marc earned his BS in Biology from Monmouth University and his MS in Microbiology & Molecular Genetics from Rutgers University.

Gabriele Gori has been in the sterile Pharmaceutical/Vaccine/Medical Device business since 1994 – in different local and global roles in multinational companies, including, but not limited to, Bausch & Lomb, Novartis, GlaxoSmithKline and Thermo Fisher Scientific. Since Dec 2021 he is the Quality Site Head of the Thermo Fisher site in Monza (Italy) leading a team of 450+ Quality associates. Prior to that, from 2010 to 2015, he had been in role as Global Head, GMP Compliance and Auditing at Novartis Vaccines in Basel (Switzerland) and later on from Sept 2015 to Nov 2021. He had been in role as Vice President, Global Head of Audit and Risk Management at GlaxoSmithKline Vaccines in Wavre (Belgium).

Within PDA, he served as co-chair of the taskforce that developed two “Points to Consider“ documents for aseptic manufacturing and of the taskforce in charge to comment to the revised draft of the EU GMP – Annex 1. Member elected of the PDA Board of Directors from 2010 through 2015, he is part of the Science Advisory Board of the association since 2015 and acting as SAB vice-chair since June 2021.

Gabriele holds a bachelor in Chemistry and a master in Quality Management.

Ghada Haddad is an Executive Director, leading the Global Quality Transformation and Regulatory Intelligence Organization at Merck & Co.  Prior to her current responsibilities, she led the Global cGMP Compliance Auditing Organization. She held several leadership positions such as the Head of the Global Quality Risk Management (QRM) Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA, and a PhD in Regulatory Sciences. She has over 24 years of experience, working in the Biotech and Pharmaceutical industries in the areas of QRM, Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, and change control. Haddad was the chair of the PDA Paradigm Change in Manufacturing (PCMO) initiative, co-chaired the Aging Facilities Points to Consider, co-chaired PDA Annual meetings, previous member of the Science Advisory Board, and the PDA Board of Directors. Haddad additionally contributes as an expert to several teams that support ICH, such as Efpia’s ICH Q9 revision team. She is currently co-leader of the GxP Audits and Inspections IG, the Quality Systems IG, and an associate editor for the PDA Journal of Pharmaceutical Sciences.

Jane Halpern, PhD, is Executive Director of Regulatory Affairs at IAVI.

Dr. Halpern has over 25 years of experience in biologics development and has held positions in government as well as both small and large biotech companies. She worked at the FDA, Center for Biologics Evaluation and Research (CBER) as a researcher/reviewer for 10 years where she reviewed applications for both investigational and commercial products.

Dr. Halpern has held senior management positions at ID Biomedical Corporation, GSK Biologics, and Novavax Inc. At ID Biomedical Corporation, she led the global regulatory team that was responsible for obtaining FDA accelerated approval of a seasonal influenza vaccine and that supported the acquisition of ID Biomedical by GSK. She has experience with all stages of product development from newly discovered entities to lifecycle management of licensed products.

Dr. Halpern currently serves as a co-chair of the PDA Vaccine Interest Group and is a member of the Regulatory Affairs/Quality Assurance Advisory Board for PDA. She received her BS in Physiology from the University of California, Davis and her PhD in Pharmacology from the University of Rochester.

Peter has over 18 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within the industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know-how.

Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is MEng in Chemical Engineering from Cornell University. He is also very active within PDA where he currently sits on the PDA BioAB, co-Leads the Biopharmaceutical Manufacturing IG, and Mobile Manufacturing Task Force.

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. She can be contacted at [email protected]

Joachim Regel has more than 26 years of experience in the BioPharmaceutical industry with focus on single-use, multi-use systems, facility and process design activities. He has held various positions at Millipore, Rommelag, LEWA Process Technologies and Merck Group including Global Key account responsibilities in Sales and European Technology management. His recent activities where mainly implementation of innovative continuous DSP Systems design, project development and consulting for  the selection of SU production systems. He was active in a Sales Development function in LIP´s in EMEA.

Actually he is active as Account Manager in DACH region, supporting clients in their efforts to ramp up Biologics production plants, developing new products in diferent stages by mainly using SU technologies and related services.

He is part of a multidisciplinary team at Merck Germany, developing and supporting local Biologics Process implementations and BDS/F+F plant projects.

Joachim graduated in Biotechnology at the University of Applied Science in Gießen, Germany.

Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. She is the recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing, 2020 PDA Distinguished Service Award and 2020 Merck Manufacturing Science & Technology Big Innovation Award. Currently, she is the co-lead of the PDA Vaccines Interest Group and member of the PDA Biopharmaceutical Advisory Board.

Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively.

Sabrina has published four technical publications, co-authored three BioPhorum Industry documents, and presented at numerous conferences.

She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.

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 BS in Chemistry from Carroll College and a PhD 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 an instructor 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.

Edward Trappler has over 40 years of industry experience that includes product development, toxicology and clinical supply manufacturing, and parenteral production. In 1992 he founded Lyophilization Technology, Inc. as a source of scientific and technical services coupled with research and education for expanding the knowledge and understanding of lyophilization throughout the healthcare product industry.

Ed has contributed to six books, authored and presented numerous papers and courses internationally. He is an active member of the Parenteral Drug Association, serving as chairperson of the Lyophilization Interest Group, Validation Task Force, and Education Advisory Board. He has lectured for the AAPS, ISPE and PDA. He has received numerous recognitions and the PDA awarded him the Gordon Personeous Award for his contribution to the PDA, the James Agalloco Award for Education, and the Martin VanTrieste Award for Outstanding Contributions to the Advancement of Pharmaceutical Science.

Eva M. Urban, currently Director at CSL Behring, leads the Global Internal Audits & Compliance team. She has 30 years’ experience in various roles – quality and operations and R&D - in Biopharma (Lonza, Celgene, CSL).  Areas of expertise are Risk Management and Quality Systems including design and implementation locally and globally, Leading Internal Auditing and Hosting Regulatory Inspections, Quality Operations, Biotech R&D, Biopharmaceutical API (DS) Manufacturing, Aseptic Processing, External Vendor Quality Oversight. Eva holds a MSc in Biology from University of Kaiserslautern, Germany.

Volunteer for PDA: member of RAQAB (Regulatory and Advisory Board), Chair of the working group for the IPEC/PDA Technical Report “QRM for Excipients”, Co-Lead PDA Interest Group Quality Risk Management, Co-Lead PDA Interest Group Quality Systems, Planning Committee Member for PDA Conferences, Co-Chair Task PDA Task Force "Remote Audits and Inspections" and received the PDA Distinguished Service Award in 2021.

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-one 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.