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Frederic Ayers
Research Scientist at Eli Lilly and CompanyFred graduated with a B.A. degree in Biology from Franklin College of Indiana in 1999, while being a student-athlete and participation in the colleges Leadership Program. After graduating, he spent two years working in the contract manufacturing industries (pharmaceutical, food) and joined Eli Lilly and Company in 2001. Since joining Eli Lilly, Mr. Ayers has held various quality and technical positions from which he has helped advance Lilly's state of regulatory compliance. He is regarded as a Subject Matter Expert in Sterility Assurance for the company's Indianapolis Parenteral Manufacturing site. Fred has the responsibility of developing, implementing and continuous improvement for the site’s sterility assurance related strategies. Additionally, Fred has been a PDA Midwest Chapter Board Member since 2014 and is currently serving as the chapter’s President.
Jeffrey C. Baker
Former Deputy Director, Office of Biotechnology Products, CDER at U.S. FDADr. Jeffrey C. Baker received a bachelor’s degree in biochemistry and molecular biology at Northwestern University, doctorate in biochemistry from the University of North Texas, and completed post-doctoral studies at the University of California, Berkeley. He joined Eli Lilly & Co in 1988, led the development and launch of several first in class biologics and subsequently supported pharmaceutical and biopharmaceutical manufacturing as a senior technical lead in the global Manufacturing Sciences and Technology unit. Dr. Baker left Lilly to be Sr. Director of Manufacturing Science and Technology at AstraZeneca and, in 2011, was appointed Deputy Director of the Office of Biotechnology Products in the Center for Drug Evaluation and Research, FDA. He left FDA in April 2021. Dr. Baker has been recognized with several citations for leadership and program development, most recently, with a 2018 FDA Honors Award for contributions to “modernizing the U.S. regulatory system for biotechnology products through sustained creative leadership and collaboration.”
Tiffany Baker
Consultant at ValSource, Inc.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. Tiff is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA 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. She can be reached at tbaker@valsource.com.
Hal Baseman
Chief Operating Officer at Valsource Inc- The Use and Misuse of Aseptic Process Simulations in the Validation of the Aseptic Processes
- PDA 374.1 Technical Report No. 22: Process Simulation for Aseptically Filled Products
Hal Baseman is chief operating officer and a principal at ValSource LLC and ConcordiaValsource LLC. He has over 40 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions in executive management and technical operations at several drug manufacturing and consulting firms. He has 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, as well as a long-time member of the PDA Training Research Institute faculty. He has been a leader, author, editor and contributor to numerous technical reports, articles, books, and presentations on subjects related to Quality Risk Management, Validation, and Aseptic Processing. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.
Danica Brown
Consultant at ValSource, Inc.Danica Brown is a Consultant for ValSource and in this role assists companies with the design and implementation of CGMPs and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, developing risk-based strategies and facilitating risk assessments. Prior to joining ValSource, Danica worked to implement a GMP risk management program by developing the procedures required and executing training in consistent use of risk management tools.
Thomas Busch
Project Director of Novo NordiskThomas Busch is Project Director in Novo Nordisk Biopharm Manufacturing Development and responsible for their future technology program within aseptic processing. He holds a M.Sc. in Molecular Biology and has been with Novo Nordisk for 19 years. In addition to expertise in GMP manufacturing of biologics, he has held several leadership and project management positions within manufacturing for clinical trials and commercial, capacity expansions, tech transfer, life cycle management and technology implementation. Thomas lives in the Copenhagen area with his wife and two kids.
Javier Cardenas
Senior Consultant at AzzurJavier Cardenas, Ph.D. is a Senior Consultant for Azzur Group, a healthcare and life sciences consulting firm. In this role, Dr. Cardenas facilitates increased compliance of sterile injectables, medical devices, and biologics manufacturing facilities through Process Development and Commissioning, Qualification, and Validation (CQV) efforts in the Southern California region. Having received his graduate degree in Molecular Biotechnology at the University of California – Irvine, his passion is driving technical advancements and knowledge in the Cell & Gene Therapy space.
Susan B. Clearly
Director Product Development of Novatek InternationalSusan B. Cleary, B.Cs, M.B.A., is the Director of Product Development at Novatek International. Previously holding the positions of Program Manager, Product Manager, and Lead Engineer for Environmental Monitoring systems. Susan has 20 years of experience in designing, developing, implementing, and managing large scale Quality Management, Environmental Monitoring and Cleaning Validation Management implementations. Susan works with pharmaceutical, biotech, and medical device companies and specializes in Data Integrity, she works with clients to streamline their procedures and manage their GMP compliantly and effectively.
Max Fernandez
Senior Director, Global Regulatory Affairs of Samsung BiologicsMax Fernandez has 20+ years of experience and leadership in global regulatory strategy, regulatory CMC, quality, and manufacturing/technical operations for biological products.
He is the Senior Director of Global Regulatory Affairs at Samsung BioLogics in Incheon, Korea. As Head, he is responsible for ensuring all site-related Quality Assurance and regulatory activities are conducted in compliance with corporate standards and applicable regulations.
Mauro Gusti
Advisor, Site External Network at Eli Lilly Italia S.p.ADr. Mauro Giusti holds a Master Degree in Chemistry at University of Florence and he is Board Certified as Chemist and as Technical Director (QP) . During the 32 years with Eli Lilly, he has covered several positions within the Lilly Manufacturing organization dealing both with Lilly plants and with CMOs in the Europe/Africa/Asia. He spent working 5 years outside of Italy, both in USA and in UK.
From 2003 to 2019 he led Technical Svcs/Mfg Science Department, with responsibility for Metrology, C&Q, Sterility Assurance, Process Validation, new processes/technology for Biotech products, including combi products. In 2009 he added the responsibility for Manufacturing Procurement.
In September 2019 he has taken a new role, as Advisor, Site External Network, dealing with external entities linked to the Lilly Sesto Manufacturing site (especially Universities) and leading a Lilly Global project for improvement of technical capabilities in Parenteral Manufacturing.
For more than 12 years he has served as a member of the Italy Chapter of PDA, with several participations to forums both as speaker and as chairman. In November 2019 he became Co- Chair for he Process Validation Interest Group. In August 2020 he was named to the PDA Science Advisory Board (SAB).
James J. Hathcock
Senior Director, Regulatory and Validation Strategy of Pall BiotechJames Hathcock, PhD is Senior Director of Regulatory and Validation Strategy at Pall Biotech, which includes responsibility for E&L characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He leads the BPSA imitative on X-ray qualification for single-use disposables and is an active member of ASTM, ASME-BPE, PDA, ISPE, BPSA, Biophorum-supplier phorum as well a USP expert panel member. Since joining Pall in 2008, James has led chemical and performance characterization of medical and biotech components, as well as relevant technical packages supporting regulatory filings. Prior to joining Pall, James served as professor of hematology at the Mt. Sinai School of Medicine in New York City, where he directed the protein purification laboratory related to drug characterization and discovery.
Maik Jornitz
President & CEO of G-CON ManufacturingMaik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a technical expert with over 30 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 11 books, 18 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.
John F. Kelly
Vice President, Quality Operations and Environment, Health & Safety at Pfizer Global SupplyJohn 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.
Stephen E. Langille
Senior Microbiology Consultant at ValSource, Inc.Dr. Stephen Langille is a Senior Microbiology Consultant at ValSource who specialized in microbiological and particulate matter contamination control of drug, device, and biological products. He holds a B.S. degree in Biology from the University of Massachusetts and a Ph.D.in Microbiology from the University of Maryland. He spent 19 years with the FDA as a Microbiology Reviewer, Branch Chief, and Director of the Division of Microbiology assessment in the Center for Drug Evaluation and Research and joined ValSource in February of 2019. He currently serves as a member of the Unite States Pharmacopoeia Compounding Expert Committee and on several Parenteral Drug Association technical committees.
Martin J. Lipa
Executive Director, Knowledge Management of Merck & Company Inc.Martin (Marty) Lipa has over 25 years of industry experience and is currently Executive Director at Merck where he leads the Knowledge Management CoE for Manufacturing. Lipa has worked in KM for over 12 years and has related experience in Lean Six-Sigma, leading transformational change and IT. Prior to KM, Lipa held various engineering, technology and automation roles. Lipa is an active member of the KM community as a regular speaker and has helped organize several KM conferences. Lipa has published several industry specific works, including as a contributing editor to ‘A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry’ (2018), as well as works in various professional journals. Lipa is currently pursuing his PhD in Pharmaceutical and Regulatory Science with an emphasis on Knowledge Management at Technological University Dublin where he is also a member of the Pharmaceutical Regulatory Science Team (www.prst.ie).
Bruce Loxley (Moderator)
Senior Manager - Audit I&TPO at GlaxoSmithKline VaccinesBruce Loxely performs regional and global auditing of GSK Vaccines and third party provider sites and functions focusing on Asia Pacific. He has 29 years in the Pharma and Vaccines businesses, variety of roles in Validation and Compliance in both Drug Substance and Drug Product Manufacturing in UK, France and Singapore.
Bruce has been a PDA Singapore Chapter member since 2014. Since February 2020 he has been PDA Singapore Chapter President
Peter J. Makowenskyj
MEng, Director of Sales Engineering at G-CON ManufacturingPeter Makowenskyj has over 15 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various technical roles in process solutions for the biotech industry prior to moving into management positions in technical and sales roles. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities with single use technologies. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their facilities utilizing G-CON’s pre-fabricated autonomous clean rooms.
Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University.
Amanda M. McFarland
Senior Consultant at ValSource, Inc.Amanda McFarland is a Senior Consultant for ValSource 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.
Ms. McFarland 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.
Ashwin Monian
Senior Engineering Specialist at Merck & Company Inc.Ashwin Monian is a biopharmaceutical engineer with deep expertise in data analytics for process optimization, automated reporting, and supply chain. He began his career at Merck supporting Liquid Vaccine Formulation and Filling, after which he moved to Small Molecule Technical Operations, where he worked to develop Big Data visualization solutions for products such as JANUMET and ASMANEX, and supported the development of the Automated CPV Platform. In his current role, he continues to advance digital tools and practices in the Biologics organization to support oncologic products like KEYTRUDA. He currently holds the title of Senior Engineering Specialist, and holds a Bachelor of Science in Chemical Engineering from the University of Delaware. On his off time, he enjoys competing in trivia (he appeared on JEOPARDY as a contestant last year), baking bread, and eating said bread.
Leonard F. Pauzer
Director Process Technology of Integrated Project ServicesLeonard F. Pauzer Director of Process technology at IPS has been in his current role for 9 years. He has over 21 years experience in the Pharmaceutical industry. Prior to his time in the Pharmaceutical Industry he spent 6 years serving in the United States Army Military Intelligence at the rank of Captain. Mr. Pauzer spent 12 years in Aseptic Manufacturing at Merck, GSK, Sanofi Pasteur, and Schering Plough. In his time at IPS, he has executed over 40 Aseptic design projects. In addition to performing design work, he also acted as the end user representative for the following companies: Pfizer, Merck, Sanofi, Takeda, Tessa, and Regeneron. In his roles at owner representative he actedd in the best interest of his clienst in the managment of equipment and process desgin. He has actively worked on Intrernational projects in Germany, Netherlands, India, Brazil, China, Singapore, Mexico, Canada, and the USA. In addition, he has been an instructor for the PDA Fundamentals of Aseptic Processing course.
Samantha Singer
Scientist I/Project Director of Lyophilization Technology Inc.Samantha Singer, Scientist I and Project Director, joined LTI in 2016. She is responsible for project coordination from concept through clinical manufacturing, including product and process development, technical support, troubleshooting, and clinical trial material manufacturing. Samantha's technical focus is visual inspection, as well as, using the residual gas analyzer during the freeze drying process.
Samantha began her career at LTI as a Development Technician I in 2016. During her time at LTI, she has been promoted to Development Technician II, Associate Scientist I, II, and her current position as Scientist I. Samantha is also a part of the training program and safety council.
Samantha received a Bachelor of Science degree in Biology from Kutztown University. After joining LTI, she earned a Master of Science degree in Pharmaceutical Sciences from Temple University. She has authored and presented poster presentations at focused industry events.
Diego A. Zurbriggen
Technical Account Manager at West Pharmaceutical Services, Inc.Mr. Zurbriggen has over 20 years of analytical lab experience, 10 of which focused on inorganic trace level analysis. As Technical Account Manager within the Technical Customer Support group of West, the focus of his role is to provide technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. He serves as the West subject matter expert on Extractables & Leachables, including elemental impurities.
Prior to this role, he was Supervisor of the Leachables/Stability group in the Analytical Labs division of West Pharmaceutical Services, Inc., the focus of his role was to develop and validate leachables methods. Mr. Zurbriggen holds a Bachelor of Science/Chemistry degree from the Gewerbliche Berufsschule Visp – Visp, Valais, Switzerland.