HORIBA Advanced Techno, Co., Ltd.
The GMP Committee for Aseptic Products is one of the technical committees of PDA Japan chapter. It is made up of ten groups, each with experts in their respective fields who are actively engaged in research and discussion. Study results of each group have been reported at annual microbiology symposium which the committee hosted and provided participants state-of-art and practical information. One of the groups, the Rapid Microbiological Method (RMM) Research Group consists of RMM users (pharmaceutical companies) and RMM system suppliers. By their collaboration, they provide application and implementation case studies from scientific, engineering, and regulatory point of view, and contribute to further improvements of quality and safety of pharmaceutical products by wide use of RMM in Japan. The speaker, Yoko Nakai represents the GMP Committee for Aseptic Products. She has been a project manager for RMM system development and applications at HORIBA Advanced Techno, Co., Ltd. since 2017. HORIBA has been a member of RMM implementation study team with Bayer Yakuhin, Ltd., and Azbil Corporation.
Ranjana B. Pathak, BSc, MBA, DHA
Dr. Ranjana Pathak is President - Global Quality, Medical Affairs & Pharmacovigilance at Cipla. Ranjana has previously held leadership roles in pharmaceutical companies such as Actavis, Endo Pharmaceuticals, Zenith Goldline, Dupont-Merck, and Thames Pharmacol.
Ranjana has a Doctorate in Health Administration from the University of Phoenix, USA; an MBA from Dowling College, New York; a Post-Graduate Diploma in Pharmaceutical & Chemical Analysis from Sophia College, Mumbai; and a B.Sc. (Hons) in Chemistry from Mithibai College, Mumbai. She has received training in leadership in pharmaceuticals and biologics at Harvard University.
As a Member of the Management Council at Cipla, Ranjana leads the organisation’s worldwide quality enterprise from the development of a product to its commercialization, and spearheads Cipla’s commitment to an uncompromising state of control with absolute regulatory compliance across all manufacturing sites of Cipla, its partners and third parties.
An industry veteran, Ranjana has over three decades of experience in pharma and brings to the table extensive industry experience in dealing with regulatory bodies around the world.
In 2006, Ranjana received the Rising Star award - Healthcare Business Association. In 2018, Woman Leader of the Year award -Future Leaders’ Summit. In 2019, National Healthcare Leadership Women Award - Zee Business.
Omkar Baburao Patil, MSc Microbiology
Cipla Limited, Goa
Omkar Baburao Patil, Associate Director, Cipla Ltd., Responsible for Microbiology activities of Goa site.
He has a Master’s Degree in Microbiology with 19 years’ of experience in Pharmaceutical industry in microbiology and Quality assurance departments.
In Cipla, he is responsible for the technical support in microbiology related activities in Sterile and non-sterile manufacturing facilities and review and implementation of cGMP and cGLP in the respective areas for Cipla Goa site.
Hoang N. Phan
Hoang Phan is a Distinguished Engineer at Genentech, a member of the Roche Group, and is serving as a Network Technology Lead within Roche. He has over 28 years of experience at Genentech with roles in manufacturing and MSAT, spanning drug substance and drug product. Hoang is currently leading Roche's efforts to introduce a fleet of modular filling systems that will allow for fast deployment, agile production across our network, and effortless technology transfers. He has presented on process validation and technology transfer topics at IBC Asia and at CASSS, along with targeted seminars provided to various health authorities.
James N. Polarine, Jr., MA
Jim Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is the current PDA Missouri Valley Chapter President.
Morgan Polen is a subject matter expert in the field of contamination control and airflow visualization in cleanrooms. Morgan has over 35 Years of experience working in cleanrooms and controlled environments in many different industries.
Morgan’s Technical Leadership:
- Internationally recognized educator in the field of contamination control
- Member of U.S. Technical Advisory Group to ISO Technical Committee 209
- Member of ASTM Subcommittee E55.06 Working Group “Guide for Critical Airflow Visualization”
- Board member of the Institute of Environmental Sciences and Technology (IEST)
Morgan has been instrumental in drafting and editing international cleanroom standards, contamination control guidelines and best practices. He has extensive experience working on cleanroom projects all over the word. Morgan 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 development of proactive contamination control strategies through pragmatic risk assessment, particle testing and airflow visualization. Morgan’s broad experience troubleshooting contamination issues has helped companies identify and remediate contamination related problems such as:
- Identify sources of particulate, microbial, fungal, molecular, and electrostatic contamination
- Assist in FDA 483 observations or warning letter remediation's
Shelley M. Preslar, MBA
Azzur Training Center Raleigh LLC
Shelley Preslar is the Founder and President of Azzur Training Center and has more than 25 years of FDA-regulated industry experience that includes time spent in both operating and consulting companies. Her technical experience spans Quality Systems, Compliance, Validation, Metrology, Maintenance, Manufacturing Operations and Training. Throughout her career she has served the industry by participating in both PDA and ISPE as a speaker, volunteer, board member, technical group leader and co-chair on teams that have produced industry technical guidance documents.
Shelley holds a Bachelor of Science in Marine Biology from the University of North Carolina at Wilmington and a Masters of Business Administration in Global Management from the University of Phoenix. She is also a proud veteran of the U.S. Army and the U.S. Marine Corps.
Aaron B. Regberg, PhD
Astromaterials Research and Exploration Science Division, NASA
Aaron Regberg is a geomicrobiologist within the Astromaterials Research and Exploration Science (ARES) Division at the Johnson Space Center (JSC). He is also the Planetary Protection Officer for the Johnson Space Center. Dr. Regberg uses culture based methods as well as next generation DNA sequencing to monitor the microbiology in Astromaterials Curation facilities at JSC. He is interested in microbe mineral interactions that may affect astromaterials as well as the potential for forward contamination from crewed exploration missions. Aaron is particularly interested in fungal ecology in the built environment.
Abby A. Roth, CMQ/OE
Abby Roth is the Senior Director of Business Operations at CriticalPoint, LLC, a healthcare training and development company. In addition to operational responsibilities, she develops curricula for CriticalPoint’s eLearning modules and live training classes. Prior to joining CriticalPoint, Abby served as the Director of Microbiology for Clinical IQ, LLC and as Quality Director at a contract pharmaceutical microbiology laboratory. She has over 16 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring, product testing, microbial contamination sources, and remediation. She holds the Certified Manager of Quality/Organizational Excellence certification through the American Society of Quality. Abby served as an expert committee member for the USP Compounding Committee from 2015 to 2019 and is an involved member of the Controlled Environment Testing Association (CETA), speaking at their annual meetings and chairing committees for the revision of three CETA Application Guides. She has been invited to speak for state Boards of Pharmacy and for organizations such as the National Home Infusion Association (NHIA) and the American Society of Health-System Pharmacists (ASHP).
Joanny Salvas is a senior manager at Pfizer, in the Global Technology and Engineering group. She has been developing and implementing Process Analytical Technologies and Rapid Micro Methods for more than 10 years, both in Solid Oral Dosages and Sterile Injectable / Bio processes. Her background in engineering, process control, and multivariate data analysis enabled her to support many successful implementations of advanced control strategies in the Pfizer network. She leads the Pfizer Rapid Micro Method steering team responsible for establishing the strategy, the evaluation and implementation as well as the development of future microbiology analytics. She continuously drives innovation forward and strives to use the best science possible in her projects.
Donald C. Singer, MA
Ecolab Life Sciences
Don Singer is Senior Microbiology Technical Consultant, North America, for Ecolab, and a Fellow in the American Society for Quality. He was formerly a GSK Senior Fellow. Don is currently Chair of the USP Microbiology Committee of Experts and has been a member since 2000. Don is also a member of the European Pharmacopeia Group 1 Microbiology Committee. He was co-chair of the PDA Task Force for the Technical Report 86, “Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing”, and was co-author of the TR 67, “Exclusion of Objectionable Microorganisms”, and is a member of the PDA Task Force for “Contamination Control Strategy” TR. He is a Certified Pharmaceutical GMP Professional (ASQ) and Certified Specialist Microbiologist (NRCM), and a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 40 years of research, quality control, quality assurance experience in the pharmaceutical, biopharmaceutical, personal care, cosmetic, and food industries. Currently Don is an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.
Aude J. Smeets, PhD
Aude Smeets - Global Analytical Technical Expert in Automation (GSK Vaccines)
- PhD, Physico-Chemistry Science (Protein Crystallography)
- Master’s degree, Chemistry Science
- 2018 – Present : Global Analytical Technical Expert in Automation (GQC-GSK)
- 2016 – 2018 : Analytical Automation Manager (Be QC-GSK)
- 2010 – 2016 : Biochemistry Lab Supervisor/Manager (Be QC-GSK)
- 2009 – 2010 : Structural Analysis Lab Supervisor (Be Indus-GSK)
- 2003 - 2009: Research & teaching assistant in Chemistry, UCL (Université Catholique de Louvain)
Shabnam Solati, MS
Shabnam Solati developed a Monocyte Activation Test to meet the end-to-end MAT needs in the industry, with pyrogen detection and quantification levels that are unprecedented. With the expertise of MAT and the knowledge regarding all the test’s potential abilities, Shabnam is dedicated to building the future of MAT beyond where it is today. Therefore, research, development and innovative technologies are continuous focus points at CTL-MAT.
Marla K. Stevens-Riley, PhD
Dr. Stevens-Riley is currently a master microbiology reviewer and Quality Assessment Lead (acting) in the Division of Microbiology Assessment in the Office of Process and Facilities, within the Office of Pharmaceutical Quality (OPQ). Previously, she was a senior microbiology reviewer in the Office of Policy for Pharmaceutical Quality. Prior to the formation of the OPQ, she was a Team Leader in the Division of Microbiology in the Office of Pharmaceutical Science, and a Team Leader and senior microbiology reviewer in the Office of Generic Drugs. She is a Center for Drug Evaluation Research (CDER) liaison to the United States Pharmacopeia General Chapters- Microbiology Expert Committee, and a co-leader on the Parenteral Drug Association (PDA) Task Force responsible for the revision of PDA Technical Report 27: Pharmaceutical Package Integrity. She was lead author on the Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes. Her recently published papers include, Parametric Release: A Regulatory Perspective (American Pharmaceutical Review), and Regulatory Pathways for Parametric Release (BioPharm Asia). During her scientific career, she has co-authored over 15 peer-reviewed scientific publications. Dr. Stevens-Riley holds a B.S. in Biology from the College of William and Mary, and a Ph.D. in Microbiology from the University of Georgia. She completed her post-doctoral training in the Department of Microbiology and Immunology at the University of Texas Southwestern Medical Center in Dallas.
Sander W. Timmer, PhD
Dr Sander Timmer is the global Director of Analytics & AI at GSK Vaccines. He and his team are leading strategic efforts to utilise data and AI to create tomorrow's healthcare. Sander has more than fifteen years of Data Science experience getting predictive and prescriptive insights from large amounts of data. Before GSK, he spent five years at Microsoft as a lead data scientist in the CTO office. He was later responsible for AI/ML adoption at pharmaceutical companies and public healthcare providers throughout the EMEA region. Sander holds a PhD in Big Data Biology and Genomics from the University of Cambridge and the European Bioinformatics Institute (EBI).
Kristin N. Valente, PhD
Merck & Co., Inc.
Kristin Valente is a Director of Technical Operations for several of the vaccines manufactured at Merck's West Point, Pennsylvania site. She has over 12 years of technical experience in vaccine and biologics, encompassing process development, commercialization, and commercial manufacturing support. In her current role, she leads a team of scientists and engineers providing technical support for drug substance, drug product, and packaging operations. In her prior roles, she has advanced the field of host cell protein impurities, developed vaccine drug substance manufacturing processes, and launched multiple vaccine products. Kristin holds a bachelor's degree (Massachusetts Institute of Technology) and a doctorate degree (University of Delaware), both in Chemical Engineering and has published several impactful peer-reviewed manuscripts. She has been active in the PDA since 2018 and has recently joined the PDA science advisory board.
Thais Vilgren, MSc
Thais holds a master’s degree in Microbial Biochemistry from the Technical University of Denmark. He has 10 years of experience from the pharmaceutical industry with 4 years in Operations and 6 years in Manufacturing development. Currently he is the Global lead for the Aseptic production process (EM, mediafill, aseptics etc.) in Novo Nordisk A/S.
Thais is based out of the Novo Nordisk site in Gentofte, Denmark.
Dawn M. Watson
Merck & Co., Inc.
Dawn Watson is a Director supporting Microbial Control at Merck & Co. She works in the Sterile & Validation Center of Excellence managing a team that leads and executes global initiatives targeted to proactively address quality and compliance risks in the sterile and low bioburden network while driving continuous improvement. Additionally, her team provides microbial contamination control and sterile manufacturing expertise to resolve critical production issues, develop innovative solutions, and ensure network alignment with industry and regulatory expectations. She is an active member in the Parenteral Drug Association and BioPhorum Operations Group. She has 26 years of experience in the pharmaceutical industry, specifically focused on sterile and low bioburden products including vaccines, therapeutic proteins and small molecules. She is trained and certified in Six Sigma and Change Management. She has held positions in validation, manufacturing and research and development throughout her career with Merck.
Sheba Zaman, BS
Sheba Zaman has been serving in a technical role at Novatek International for 20 years. With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems such as LIMS, Stability, Environmental and Utility Monitoring, Cleaning Validation and Quality Management Systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade managing change and implementation of software solutions, including establishing procedures, work instructions, validation scripts and training programs. Key areas of expertise include Data Integrity, Process Improvement, Data Analysis/Trending, FDA compliance, Software Implementation and Optimization in a regulated environment. She also teaches PDA tri courses for various EM trending topics and is currently serving as the President of Parenteral Drug Association’s (PDA) Southern California Chapter.