Check out this year’s line-up of engaging and inspiring speakers.
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.
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.
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.
Tiffany Baker is a quality risk management and microbiology consultant with Concordia ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiffany is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training and Research Institute, and a Trainer for the PDA training courses on quality risk management foundations as well as practical application of QRM tools. She is also co-lead for the PDA task force on Remote Audits and Inspections. Additionally, she was a member of the core team who co-authored the ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process. She has a BS in microbiology from the University of Rhode Island and an MBA from Providence College.
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.
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:
GLENN E. WRIGHT is currently the VP Scientific and Regulatory Affairs, PDA . Glenn has more than 30 years of experience in the pharmaceutical industry. Previously, he served in various technical and senior leadership positions at Exelead, Eli Lilly, Amgen, and Pfizer. He has extensive technical, regulatory, and quality expertise in both small molecule and biologic drug substance manufacturing and sterile injectable drug product production. Glenn has served on the PDA Board of Directors, Science Advisory Board, and Program Advisory Board. In addition, he has chaired numerous PDA meetings, including the PDA/FDA Joint Regulatory Conference and the PDA Annual Meeting. As well as chairing many industry task force groups, including the PDA Aging Facilities Task Force and PQRI’s Post Approval Changes for Aseptic Processing Working Group. He is a frequent speaker at PDA events. Glenn received his BS and MS degrees in Microbiology from Southern Illinois University
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.
Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a technical expert with close to 35 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published multiple books and book chapters and over 100 scientific papers. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces. He is working member of Biophorum, ASTM, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. He recently has been recognized as one of the top ten global industry influencers. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.