Check out this year’s line-up of engaging and inspiring speakers.
Susan Schniepp has over 40 years of quality assurance experience in the pharmaceutical industry. She has earned several awards from the PDA, including Distinguished Author Award, Distinguished Service Award, and Gordon Personeus Award.
Sue’s publications include the book, Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, for which she was awarded the 2007 PDA’s Distinguished Author Award. She co-edited and contributed to the books Pharmaceutical Outsourcing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers.
Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011- 2013 and from 2016- 2019 and is currently the Chair Elect (2020 - 2022). Sue has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working part of the working group writing a technical report relating to manufacturing data integrity issues and participating in PDA’s standard setting activity regarding purchasing controls.
In addition to PDA activities, Sue is an editorial advisory board member and columnist for Pharmaceutical Technology (since 2007) and BioPharm International Magazines. She holds a bachelor of science degree in Microbiology from Northern Illinois University.
Kristen Dowling has over twenty years of experience in the pharmaceutical industry. She is currently a Senior Manager in Quality Assurance for Amgen in West Greenwich, Rhode Island. She oversees a multi-layered team responsible for QC Equipment Management, QC Investigations, Supplier Quality Management, and Analytical Quality Systems. Previous to this role, Kristen worked in Corporate Quality Control where she supported global Quality Control strategic objectives to ensure alignment with regulatory compliance expectations and business requirements. She continues to support the network as the global process owner for both the Analytical Investigations and Method Invalid Tracking/Trending processes. Kristen holds a Bachelor of Science degree in Microbiology from the University of Rhode Island.
Ivy Louis, Founder of VIENNI TRAINING & CONSULTING LLP with a Master's degree in Pharmaceutical Sciences and an MBA(Human Resource Management).
32 years of my work experience spans teaching, pharmaceutical manufacturing/quality and service provision. VIENNI Training & Consulting LLP has been involved with consultation (optimizing unit operations for sterile product manufacture), training and educational services from 2010. The areas of support for pharmaceutical and biopharmaceutical operations are in both the core areas of manufacturing, quality assurance & softer elements of human behaviour. Altering approaches to understanding excellence at work with enhancing performance standards is a distinctive feature of our training and consultative services. Having been associated with PDA Inc.(www.pda.org) from 2003, as a member, I have participated in the activities of the PDA Chapter in India, from 2013 onwards. I have held various positions of Chapter Board between 2013-2019 and am the current past President of the Chapter. I have been a Member of the Steering Committee for Awards in 2017, a Member- PDA letter Editorial Committee, a Member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing in addition to being a member of the Science Advisory Board.
Jason Kerr is an experienced quality and regulatory professional and has been a champion in engaging, connecting, and promoting regulatory compliance in the dynamic biopharmaceutical landscape. Driven by data, he takes pride in providing the best possible outcome while remaining compliant and efficient. As a GXP Senior Specialist at Redica Systems, Jason's goals include enhancing the quality and regulatory knowledge and advancing key topics, such as data integrity, throughout the industry. He previously worked at Amgen where he monitored global regulatory intelligence and identified quality requirements to be triaged, assessed, and implemented to ensure compliance. This included designing and implementing a system to track changes being implemented and provide regular updates to key stakeholders.
Amanda McFarland is a Senior Consultant for ValSource Inc., and in this role, assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate a global risk management program by developing the procedures required and training the organization in the execution of consistent risk management tools.
Amanda currently serves as the PDA QRM interest group co-lead, the co-chair of the PDA Membership Advisory Committee (MAC) the PDA SE chapter Secretary.
Melissa Seymour is the Chief Quality Officer for Biogen Inc. In her current role Melissa leads the PO&T organization in setting the quality strategy, implementation of quality processes and systems, and development of talent to ensure the highest level of quality in the pharmaceutical industry. Prior to this, Melissa served as VP of Global Quality Control assuming responsibility for the strategy and implementation of Global QC testing worldwide. Additionally, she spent several years as the VP of Corporate Quality with responsibility for global compliance and quality systems including management of Quality Systems, Internal and External Auditing and Global Affiliate GMP oversight.
Melissa holds BS degrees in both Biological Sciences and Biochemistry from NC State University and an executive MBA from Duke University. She has over 25 years of experience in the quality arena including quality positions at Novo Nordisk pharmaceuticals and Glaxo Smith Kline.
Melissa has been involved in the influencing of regulatory guidance through her participation on non-profit Boards of the PDA as well as Rx-360. She has been an advocate for simplification of PAC processes, participating in industry forums, writing articles and interacting with regulators. Melissa is an ASQ Certified Quality Engineer, Certified Quality Auditor and Certified Quality
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.
John F. Kelly is Vice President, Quality Operations and Environment, Health & Safety, responsible for leading the overall Quality function for Pfizer and for leading global EHS across the Company. John is a member of the PGS Leadership Team. John is a member of the Pfizer PAC Board of Directors and past member of the Pfizer PAC Steering Committee and is Chairman of the Board of Directors of Zydus Hospira Oncology Private Limited, a joint venture between Pfizer and Zydus Cadila. He is also a member of the Board of Directors of The Patterson Club, Fairfield, CT, a member of the Board of Trustees of Wakeman Boys & Girls Club, a member of the Worcester Polytechnic Institute Engineering Dean’s Advisory Board, and past co-President of the Fairfield College Preparatory School Fathers’ Club.
John joined Pfizer in 1982 as Plant Services Engineer at the Brooklyn, New York site. Prior to his current position, he held assignments in New York, (Technical Services, Plant Network Strategy, Strategy, Transitioning Sites), Brooklyn, New York (Engineering, Manufacturing), Barceloneta, Puerto Rico (Manufacturing, Quality Operations) and Vega Baja, Puerto Rico (Site Leader). He assumed his current position in 2017.
John holds a B.S. in Chemical Engineering from Worcester Polytechnic Institute and an M.B.A. in Operations Management from Pace University.
Jane Halpern, Ph.D. is an independent consultant for the biologic and biotechnology industries, specializing in regulatory strategy and CMC guidance.
Dr. Halpern has over 25 years of experience in biologics development and has held positions in government (FDA, NIH) as well as both small and large biotech companies where she held senior management positions. 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.
Co-founder and CSO of Aizon. Co-chair of the PDA Biomanufacturing Interest Group and co-chair of the 2021 PDA Robotics and Automation Conference, AI Xavier Manufacturing Core Team lead and SME in the Spanish Parliament on big data and artificial intelligence. Toni teaches Big Data and AI at the University (UAB, ODBS and Xavier University of Cincinnati).
Dr. Amin Khan joined GreenLight Biosciences in April, 2021 as Chief Science Officer, Human Health. Prior to joining this mRNA-based biotech company, he spent 25+ years in pharmaceutical and vaccines R&D, encompassing small and large molecule drugs, biologics and vaccines. Most recently, he has led technical R&D teams at Novartis and GSK, where his teams's contributions enabled the development and launch of Bexsero® and Shingrix®, vaccines, and the accelerated development of mid-stage vaccine assets, including for RSV, HSV, and CMV. He also held accountability for scientific gating and prioritization of GSK’s vaccine discovery portfolio.
Dr. Khan led GSK Vaccines R&D Acceleration (March 2019 – March 2021) with accountability for end-to-end acceleration of the vaccine portfolio. He joined GSK (2015) to head Global Vaccines Technical R&D, having held an equivalent position at Novartis Vaccines (2011-2015). Prior to joining the vaccines industry, Dr. Khan spent more than 20 years working on small molecule drug, and biotherapeutic product, process and analytical development; Trinity Biosystems, Inc (2008-2010), Eli Lilly and Company (1998-2008), West Pharmaceutical Services (1993-1998), and Enzytech, Inc (1989-1993). He holds a Ph.D., in Pharmaceutical Sciences from the University of Nottingham, U.K.
Stephan Krause is a results-driven leader with technical, managerial, and executive experiences. Proven background in directing quality and technical functions within global operations. Experienced as a key team member in the Biologics Development and Supply Quality Leadership Team.
Accomplished leader of industry quality-focused task forces to improve and standardize best practices. Breadth of exposure to various product types, including mAbs, ADCs, Coagulation Factors, ATMPs, Small Molecules, Biosimilars.
Accomplished PDA Task Force Leader for:
Hal Baseman is Chief Operating Officer and a Principal at ValSource Inc. He has over 42 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has previously held positions as the Chair of the PDA (Parenteral Drug Association) Board of Directors, the Co-Chair of the PDA Science Advisory Board, the Co-Leader of the PDA Aseptic Processing Points to Consider Task Force and the Co-Leader of the PDA Process Validation Interest Group. He is currently the Co-Chair of the PDA Annex 1 Response Team, as well as a long-time member of the PDA Training Research Institute faculty. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.
Chris Smalley has retired from Merck, where he had responsibility for innovative implementation and validation, including Single Use Systems and Isolators globally. He now is a consultant for Valsource, focused primarily on Compounding Pharmacies. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier he had worked for the Johnson & Johnson family of companies, where he was a Plant Manager.
Chris retired after 21 years of service as a LtCol in the USAF. Chris practiced as a compounding pharmacist across the military hospital system, compounding intravenous solutions and total parenteral nutrition products. Chris is a graduate of the Philadelphia College of Pharmacy. His graduate education includes a MBA from TU Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from TU School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University.
Chris has been a member of the PDA Board of Directors, the PDA Science Advisory Board, and is a member of the ISPE Disposables CoP Steering Committee and the Pharmaceutical Engineering Committee.