PDA Trainers

Bryan Abney

Syner-G Biopharma Group

Mr. Abney has been in the pharmaceutical industry since 1993 working for a variety of companies from small start-ups to large industry giants. Most recently, he is the head of quality at Syner-G Biopharma Group, a consulting firm specializing technical, regulatory, and quality aspects of pharmaceutical development and submission. Today, Mr. Abney leads a team assisting companies with building quality systems, creating strong quality cultures and strategies, and day-to-day QA support. He holds a M.S. Degree from the University of Missouri, St. Louis in Organic Chemistry.

Virginia Andreotti-Jones

ValSource

Virginia Andreotti-Jones is a consultant with ValSource, focused on providing innovative approaches to Quality Risk Management (QRM). Throughout her career, Virginia has played a crucial role in Quality Risk Management, Quality Event Investigations, and Quality Systems. Virginia is highly skilled with a well-rounded expertise in the Quality organization. In addition to QRM, her expertise specifically includes Quality Event Investigations, Quality Systems, Human Error Reduction (Human Performance), QC Equipment Qualification, Change Control, and Project Management. Virginia is also an active volunteer with PDA and currently serves on the Board of the Pacific Northwest Chapter of PDA. She holds a BS in Chemistry from Gonzaga University.

Frederic B. Ayers

ValSource, Inc.

Fred, a 1999, graduate of Franklin College of Indiana with a Bachelor of Arts (B.A.) in Biology. While at Franklin College he was a 4-year student-athlete and participated in the institution's Leadership Program. After graduating, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001. Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a global Sterility Assurance Subject Matter Expert. For Lilly–Indianapolis Parenteral Manufacturing, he had the responsibility of the development, implementation, and continuous improvement for all aspects of the site's sterility assurance program. As an Advisor for the Global Quality Standards organization, Fred was responsible for ensuring that Lilly Quality Standards for the Sterility Assurance Programs evolve with global regulatory expectations. Currently, Fred provides consultation services to the pharmaceutical and biopharmaceutical industries, specializing in Contamination Control, Sterility Assurance, and Microbiology. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter of PDA has a Board Member since 2014 (President from 2020-2021) including a Task Force Member for PDA Technical Report 90. Fred is a committee member for many workshops and conferences, and a standing member of the PDA Scientific Advisory Board.

Tiffany Baker MBA

ValSource, Inc.

Tiffany Baker is a quality risk management and microbiology consultant with ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, facilitating risk assessments, 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 [email protected].

Hal Baseman, MBA

ValSource Inc.

Hal Baseman is the Chief Operating Officer and a principal at ValSource Inc. Mr. Baseman has over 40 years of experience in the pharmaceutical, medical device, and biotechnology industry. He has been the Chair of the PDA Board of Directors, the Co-chair of the Science Advisory Board and Co-leader of the Process Validation Interest Group, Co-chair of the EMA Annex 1 comment repose team, Co-leader of the task force on revision of Technical Report No. 22 – Aseptic Process Simulations, Co-leader of the task force for Technical Report No. 44 – Risk Management of Aseptic Processes, Co-leader of the task force for Technical Report No. 60 on Process Validation , Co-chair of the Committee for response to the FDA and the EMA Process Validation Guidance, and the Co-chair of the expert task force for the revision to Aseptic Processing Points to Consider Parts 1 an 2. He is the Co-lead for the Kilmer regulatory collaboration team and contributor on matters related to aseptic processing.

Mr. Baseman holds an MBA from LaSalle University and B.S. Biology from Ursinus College.

Lauren Bertonazzi

Sartorius

Ms. Bertonazzi has been with Sartorius since 2021 as a Field Application Specialist covering separations technology in the Mid-Atlantic region. She is responsible for training and technical support for end users of normal flow and tangential flow filtration and filter integrity testing technologies. Her previous 13 years of experience include working as a biotechnician in viral vaccine manufacturing, working as a quality control analyst for a topical pharmaceutical manufacturer, and working at a veterinary drug manufacturer as a manufacturing specialist. She holds a B.S. degree in Biological Sciences from Rutgers University. 

Paul Bilotti

Wilco AG

Paul Bilotti has been with Wilco's Sales Manager and Systems Consultant for customers in the US, Canada and Puerto Rico since 2013. Paul holds a B.S. degree in Electrical Engineering from Manhattan College, and a Masters in Computer Science from Stevens. He's been involved in the design, debug, deployment, and customer training of a variety of test system designs ranging from RADAR, to web laminating and converting, to pharmaceutical inspection systems since 1989. He (normally) travels a lot, visiting customers around the US and Canada, but is active in his local PDA and ISPE chapters whenever he's not on the road, and is happiest when he can help someone in need of support, advice, or equipment to get their job done.

Chuck Bornhoeft

Rion

Chuck Bornhoeft brings over 20 years of biotech and pharma experience to Rion as Vice President of Quality Operations. Mr. Bornhoeft is a proven quality leader with a passion for building and maintaining a strong quality culture. Prior to joining Rion in July 2021, he has supported biologics, small molecule NDA and ANDA products, dietary supplements, and cosmetic products throughout his career at Upsher-Smith Laboratories and Johnson and Johnson. He has extensive experience with internal and external manufacturing and packaging production, quality systems, product development, process improvement, laboratory oversight, and on-market product support. In addition to his work experience, Mr. Bornhoeft is a current Regulatory and Quality Advisory Board member with the Parenteral Drug Association. He holds a MS and BS in chemistry from Villanova University and the University of Wisconsin-Madison.

Richard S. Brown

MVA Scientific Consultants, Inc.

Mr. Brown is a forensic microscopist with over 30 years’ experience in the characterization of small particles using light and electron microscopy. Mr. Brown's expertise focuses on method development and foreign particulate isolation and analysis in the aerospace, manufacturing, pharmaceutical and medical device industries. Mr. Brown joined MVA in 1991 and holds an M.S. in Forensic Chemistry from Northeastern University in Boston, MA, and is a diplomat of the American Board of Criminalistics.

Renee Buthe

STERIS Life Sciences

Renee Buthe has been a member of STERIS Life Sciences Contamination Control Solutions as Technical Services Specialist since October 2021.  In this role, Renee has responsibility for providing global technical support primarily for Sterility Assurance (i.e. biological and chemical indicators) and Sterility Maintenance Products (i.e. sterilization wrapping), application and validation.

For 5 years, Renee has held positions within the Pharmaceutical Industry, specializing in environmental monitoring, sterility assurance, disinfection, sterilization and contamination control in parenteral drug manufacturing. 

Renee holds a bachelor’s degree in Biology with a minor in Animal Sciences from the University of Kentucky.

David Chesney MSJ

DL Chesney Consulting, LLC

DAVID L. CHESNEY, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii. Mr. Chesney holds an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of PDA, where he serves on the faculty of the Training and Research Institute. He is also active in the Food and Drug Law Institute and RAPS.

Gregg H. Claycamp, MS, PhD

Dr. Claycamp is an expert in risk management and decision making who recently retired from the Senior Biomedical Research Service (SBRS) at the FDA. He spent nearly twenty years at the FDA working on human health risk analysis related to both human and food animal drugs. Dr. Claycamp joined FDA-wide groups on the 21st Century GMP Initiatives 2002 and shortly after proposed risk ranking and filtering methods for risk-prioritizing GMP surveillance inspections. In 2007, he joined CDER’s Office of Compliance and subsequently served as Director of the Div. of Compliance Risk Management and Surveillance. Dr. Claycamp worked on a portfolio of risk problems, risk management systems, and decision analysis tools for various levels of drug review and post-marketing risk management. He made frequent research and training presentations at industry and scientific conferences and publishes on these topics; reviews for a variety of risk and regulatory science journals; and leads courses in Risk Analysis and Risk-Informed Decision Making. Dr. Claycamp also served on international working groups who developed “quality risk management” as a systems-based approach integrating quality systems and risk management for drug manufacturing. He was the regulatory lead for the final, internationally-harmonized guideline, ICH Q9: Quality Risk Management. During the recent past, Dr. Claycamp participated in the design and delivery of risk management training for the FDA, PDA, and the PIC/S organization.

Dr. Claycamp’s AB is in Human Biology from Stanford University; MS and PhD degrees are in Radiological Health Engineering from Northwestern University. Prior to joining the FDA, Dr. Claycamp was a Professor at the University of Pittsburgh where he directed graduate training programs in Risk Assessment and Radiation Health while maintaining an active research career including ~80 publications. He previously served on faculties of Radiation Biophysics at the Univ. of Kansas and the Dept. of Radiology at the Univ. of Iowa.

William Collentro

Mr. Collentro has dedicated more than 40 years to water treatment and purification. He obtained both his Bachelors and Masters Degrees in Chemical Engineering from Worcester Polytechnic Institute. He is a Senior Consultant/Subject Matter Expert for water purification systems. Mr. Collentro is an Adjunct Associate Professor at Temple University QA/RA Program and an instructor at the Parenteral Drug Association Training & Research Institute. He has published or presented over 150 technical articles including a text on Pharmaceutical Water Systems, chapters in other texts, and is an inventor of water system process patents. He is a current or past member of several technical societies including AIChE, ACS, AFS, AWWA, PDA, NEWWA, and WQA.

Joseph Copp

Sartorius

Mr. Copp has worked in the biopharmaceutical field since 2015, starting in contract manufacturing at Patheon in St Louis, MO. Recently, he worked as a Bioprocess Engineer for Novartis Gene Therapies, focusing on cell culture and clarification for AAV production. Today, Mr. Copp works as a Field Application Specialist for Sartorius, supporting separations products virtually and on-site through trainings, demos, and small-scale experimental work. He holds a BS in Chemical Engineering from the University of Notre Dame.

Dave Crance

Particle Measuring Systems (PMS)

David Crance is the Life Sciences Sales Manager for Particle Measuring Systems and has been in the Life Sciences business for over 30 years. He has lectured for pharmaceutical societies and organizations throughout the USA and Asia on environmental monitoring systems and their cGMP regulations. He has been an Instructor at the Parenteral Drug Association (PDA) headquarters in Bethesda, Maryland for the last fourteen years. David has been involved in the design and implementation of almost 500 environmental monitoring systems. In his role as Life Sciences Sales Manager, he works with leading engineering firms and manufacturers in the designing of Environmental monitoring systems.

Amanda Curtis

ValSource, Inc.

Amanda Curtis is a Microbiology Consultant at ValSource with over 10 years of experience in medical and pharmaceutical microbiology. She received her bachelor’s degree in Microbiology from Purdue University. Amanda’s pharmaceutical expertise is in the field of Advanced Therapy Medicinal Products (ATMPs), with experience bringing cell and gene therapy products through FDA Pre-Approval Inspections.

She is experienced in complex investigations, sterility testing, and microbial and contamination control with a focus on risk-based approaches to environmental monitoring.

Jose Del Rio

MVA Scientific Consultants, Inc.

Jose Del Rio has nine years of experience in microanalysis, specializing in submicron particle isolation and sample preparation in a clean environment. He is skilled in the use of scanning electron microscopy-energy dispersive x-ray spectrometry (SEM-EDS) and optical microscopy, including reflected/transmitted light, brightfield/darkfield, and polarized light microscopy, in the identification of particulate. Jose is also trained in the characterization of organic materials utilizing infrared spectroscopy.

Allison L. Dill, PhD

Eli Lilly and Company

Allison Dill, Ph.D. is a Principal Research Scientist in Bioproducts Research and Development at Eli Lilly and Company, Indianapolis, IN. She received a BS in Chemistry and Biology from Indiana University and worked for 4 years as an analytical chemist in Product Research and Development before attending graduate school. She received her Ph.D. in Analytical Chemistry from Purdue University, studying imaging mass spectrometry for disease state characterization. While at Lilly, she has been responsible for the analytical control strategy of many solid oral and parenteral dosage forms and has contributed to many regulatory submissions. Her contributions were recognized with an Eli Lilly Top 100 Innovator Award. She has contributed to the corporate CCI strategy as well as the strategy for multiple molecules with a concentration in on-line high voltage leak detection for 100% inspection. In her current role, she provides technical leadership enabling the delivery of the bioproducts portfolio within a complex global network with responsibility for the analytical control strategy of both drug substance and drug product across all phases of development.

Deborah J. Drew

Drew Quality Group, Inc.

Deborah (Debbie) Drew is the President and CEO of the Drew Quality Group, Inc. a tax exempt 501(c)(3) corporation dedicated to manufacturing high quality generic drugs with a diverse and inclusive workforce in the USA. The Drew Quality Group, Inc.’s mission is to address drug shortages in the United States while on-shoring high quality manufacturing jobs through the establishment of domestic manufacturing capacity, and enrichment of their local communities and science and engineering education.

Debbie is a veteran of the US Army and has, over a 26-year period, worked as a machinist while completing her Bachelor Degree then after graduating was a Manufacturing Management Access candidate at SmithKline & Beecham, then worked as an engineer in increasing level positions at AstraZeneca, then as a consultant for Parexel Consulting, then a Director at Avecia Biotechnology, then a Manager at Shire, then a Senior Engineering Manager at Abbott Laboratories, and then a Senior Engineering Manager at AbbVie before launching the Drew Quality Group, Inc. in 2014.

Deborah has an Associate Degree in Liberal Arts from City Colleges of Chicago (US ARMY extension program), a Bachelor of Science in Mechanical Engineering from Widener University, and a Master in Business Administration from the University of Phoenix.

Deborah teaches and lecturers on engineering topics for industry organizations, local colleges, universities, and participates in the Science, Technology, Engineering, and Mathematics (STEM) Education Coalition outreach activities to middle school and high school students.

Also, Debbie is the proud parent of two adult children, a daughter and a son.

Danielle Duran

Nestle Health Science

Danielle is the Director, GxP Training at Aimmune Therapeutics, a Nestle Health Sciences Company, where she leads the development of a GxP Learning Organization and supports Quality in Learning and Training Systems. She has spent nearly 20 years learning and continuous improvement in biotechnology, tech startups, K-16 education, philanthropy, and non-profit. Her expertise is in leveraging and understanding how people learn from a neurological perspective combined with how people understand behavior and social interactions to drive meaningful change. She arrived at Nestle via Aimmune, and before that, BioMarin, where she led a training team in Technical Operations, led global initiatives for training system improvements, and consulted globally on effective training design. Danielle lives in Marin County with her 8-year-old daughter and enjoys time in outdoor sports, traveling, and building global relationships to support effective learning.

Katie Falcone

Katie Falcone graduated with a BS degree in Biomedical Engineering from Drexel University in Philadelphia, PA. After finishing her undergraduate study, she joined West Pharmaceutical Services where she served in a number of technical roles. In 2021, Katie graduated with her MSE in Bioengineering from the University of Pennsylvania in Philadelphia. Katie has focused both her career and educational pursuits around primary parenteral packaging systems from research and development to implementation in medical devices to technical sales support.

Katie joined Datwyler in 2021 as a Scientific Support Manager working side-by-side with Key Account Managers, focusing on technical sales management and mitigating technical issues for Datwyler’s largest clients.

Wayne Garafola

Sartorius-Stedim Biotech

Mr. Garafola received special training and work experience in membrane filtration technologies, integrity testing, pre-filtration and sterilizing filters, cross flow separations, membrane adsorber (chromatographic) separations, Utility IQ/OQ (air/gas/water/steam), and various filtration applications. He completed a Bachelor of Science degree in Microbiology at Pennsylvania State University. He has over 27 years of experience in the pharmaceutical and life science industries, working in a variety of positions from QA, R&D, Validation Services, and Technical Services.

He shared the 2016 James P. Agalloco Award, for PDA TRI faculty member who exemplify outstanding performance in education, with co-trainer, Maik W. Jornitz. He has been a member of PDA for 25 years and teaching at PDA TRI since 2006.

Stephanie Gaulding

Pharmatech Associates

Ms. Gaulding is the Managing Director at Pharmatech Associates, Inc. She draws on almost 30 years in quality and leadership roles to develop and deliver efficient, scalable, and sustainable quality management systems. Her consulting services have helped both start-up and industry-leading clients successfully pass inspections by global health authorities on their journey to product approval and launch. Ms. Gaulding is an ASQ Certified Quality Auditor and ASQ Certified Pharmaceutical GMP Professional and is actively involved in PDA, ISPE, and ASQ. She holds an M.Sc. in Biotechnology from Johns Hopkins and a B.Sc. in Biology from Virginia Tech.

Gabrielle Gehron

Datwyler

Gabrielle is a Philadelphia-based Scientific Support Manager who joined Datwyler Pharma Packaging in 2022. From 2015 to 2019, she attended Widener University and completed her Bachelors' and Masters' degrees in Biomedical Engineering. She has since worked in the pharmaceutical packaging industry, helping major drug companies determine how to safely and effectively package their drug products. Gabrielle has taken a special interest in many related topics, including the process of PERFECTing delivery systems, as well as the benefits of increased degrees of automation in the manufacturing process.

(Personal) In her free time, Gabrielle enjoys reading, cooking, and spending time with her husband and dog.

Faith Gilmore

MilliporeSigma

Faith Gilmore is a Senior MSAT Engineer & Technical Consultant at MilliporeSigma, specializing in sterile filtration and integrity testing. She started her career with MilliporeSigma as a product development engineer developing pleated sterilizing-grade and prefilter devices. She later moved into a Quality role within single-use assembly manufacturing working on key quality initiatives, including a technology transfer to a new production facility in China. Today, she works in the commercial organization, supporting customers in the areas of sterile filtration and integrity testing through consulting, training, process reviews, and projects. Faith holds Bachelor's and Master's degrees in Biomedical Engineering from Worcester Polytechnic Institute.

Marc Glogovsky MS

ValSource, Inc.

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 and on the planning committee for the PDA/FDA Joint Regulatory Conference. Additionally, Marc has chaired several Technical Reports and Points to Consider publications and served on both the Science and ATMP Advisory Boards and the former co-chair of the Microbiology/EM Interest Group. 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 support of PDA’s international activities. Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology & Molecular Genetics from Rutgers University.

Norman Goldschmidt

Genesis AEC

Mr. Goldschmidt is an internationally recognized expert and author on environmental control and the integration of facilities and processes for global compliance, operating efficiency and sustainability.

Norman has over 35 years of experience, spanning the many types of facilities and processes necessary to bring Life Science products from R&D to market… and beyond. He’s an author and instructor for the NJIT Masters of Pharmaceutical Engineering program as well as ISO, FDA, NIH, USDA, HCA,TGA, ISPE, PDA and others.

His experience spans many modalities and dosage forms including: ATMPs, Sterile Processing, Pharmacy Compounding, Radio-pharmaceuticals, Biologics, Medical Devices, HPAP and Small Molecules. He holds multiple patents in pharmaceutical process and HVAC.

Norman is the President of Genesis AEC, a full service Life Science Consulting, A&E, CM and CQV firm. Prior to joining Genesis Norman was with Bristol-Myers Squibb for 20 years in multiple roles, culminating as the Executive Director of Global Engineering.

Andrew W. Goll

Weiler Engineering, Inc.

Andrew Goll is a highly experienced Pharmaceutical manufacturing executive with more than 20 years of experience in Pharmaceutical manufacturing and Blow\Fill\Seal (BFS) Machine manufacturing and design.

Current role as Weiler Engineering, Inc’s. Chief Operating Officer and is a member of the site leadership team. Weiler Engineering produces between 10-15 ASEP-Tech BFS systems across 6 product lines, which are exported around the world. Andrew has worked for Weiler Engineering for 20 years and has held a range of roles for Weiler Engineering during these 20 years.

Beth Haas MChE

Haas Pharma Consulting

With over 30 years in the industry, Beth has versatile experience across product lifecycle phases covering product development, CMC requirements, cGMP manufacturing, and CDMO management focusing on new product introductions and technology transfers for both APIs and drug products. She enjoys partnering with CDMOs across all platforms, working closely with procurement and supply chain to ensure compliance, and establishing strong relationships between the key functional areas to achieve regulatory approval. Beth is highly skilled in global team leadership, process development and engineering, quality risk management, GMP quality systems, and CMC regulatory filings. Currently, Beth is a member of the RAQAB, co-leads the Technology Transfer interest group for PDA, was a co-leader for the recently released PDA Technology Transfer technical report (TR-65), and was an author on the ISPE Technology Transfer guide, 3rd edition.

Martin Haerer

Rommelag CMO

After receiving his Ph.D. in Pharmacy in 1990, Dr. Martin Haerer started at Holopack Verpackungstechnik GmbH as Assistant of the Production Manager. In the following years, he managed different projects in Production, Quality Control and Quality Assurance to improve the Quality System and Production.

In 2005, he was appointed Production Manager and Qualified Person, and since 2008, he has been Director for Pharmaceutical Affairs, responsible for all pharmaceutical and regulatory aspects in the company. Additionally, in 2001, he was elected Member of the Board of the BFS-IOA Association as Regulatory Officer.

Deborah Havlik

DAHavlik Consulting

Deborah Havlik has been working as an independent consultant with expertise in microbiology and sterilization for the past four years. Prior to that, she was the Director of R&D Microbiology in Pfizer and was responsible for supporting the development of microbiological test methods and sterilization processes for drug products, biologics and combination products globally. Deborah has industry experience working in device, contract sterilization/contract laboratory and pharmaceutical companies. She has developed sterilization processes in ethylene oxide, moist heat, dry heat and radiation and also evaluated novel sterilization technologies. She is active with the Parenteral Drug Association and with AAMI and ISO on multiple working groups developing sterilization standards, and is a member of the USP Small Molecules 1 Expert Committee.

Casey M. Jarvis, MPS

MVA Scientific Consultants

Casey Jarvis has worked as a research scientist at MVA Scientific Consultants for five years isolating visible and sub-visible particles under an ISO 5 clean bench. Her background in chemistry and forensic science provides a strong foundation for investigating and characterizing foreign materials found in products and packaging. Casey specializes in chemical analysis using light microscopy and microspectroscopy techniques, such as FTIR and Raman microspectroscopy.

David Jaworski MBA

PDA

David Jaworski has extensive experience in pharmaceutical manufacturing, international business management, and regulatory science. With a background of over 38 years in industry and most recently at the FDA, he strives at the PDA as a Senior Advisor to help members apply world class pharmaceutical and biotechnology practices, principles and methods to improve the quality of manufacturing facilities, employees, processes, and drug products. He has a Bachelor of Science Degree in Microbiology from Pennsylvania State University and a Master of Business Administration Degree in Operations and Management from Syracuse University. He has worked for major pharmaceutical companies, consultancies, and also at biotech start-up companies. At the FDA he started his career as a Consumer Safety Officer working in the CDER Office of Compliance and retired from the FDA as a Senior Policy Advisor in the Office of Manufacturing Quality. His expertise includes both sterile and non-sterile products; biotech API’s, devices, pharmacy compounding, as well as building new sterile facilities and innovative manufacturing processes. He has worked on the PDA/FDA Joint Conference planning committee, is a past Co-Chair, and has been a speaker at several PDA conferences. He also is a Vice President at Jaworski Associates, LLC.

Maik Jornitz

BioProcess Resources LLC

Maik W. Jornitz, Founder & Principal Consultant BioProcess Resources LLC, is a 35-year veteran of the industry. He is highly experienced in single-use bioprocesses, aseptic processing, and a subject matter expert in sterilizing grade filtration. He has published multiple books and book chapters and over 130 scientific papers on various bioprocessing and facility design topics. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces, including the EU Annex I response team. He is working member of ASTM E55, an advisory board member of the Biotechnology Industry Council, ICAV, Bondwell and board member of DIANT Pharma and Sunflower Therapeutics. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities frequently. He worked 26 years for Sartorius, with his last role being the SVP for Global Product and Marketing Management Bioprocess and 10 years for G-CON in the President & CEO role. He received his MEng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.

Sean Kerrigan

STERIS

Sean is a Sr. cGMP Consultant for STERIS, a U.S. based manufacturer of sterilization wrapping solutions and pre-sterilized cleanroom materials. Working within the Barrier Products Solutions group at STERIS, he has over 15 years’ experience in the industry, identifying and providing solutions for pharmaceutical and biotechnology clients around the globe with needs related to process improvements in component preparation, maintaining sterility, particulate reduction and aseptic technique.

As a subject matter expert on Good Manufacturing Practices for component preparation, maintaining sterility from the autoclave to the production area, and facilitating aseptic technique, he has been an instructor with the Aseptic Training Institute (ATI) since 2008, conducting trainings at their Clayton, NC and University of Cardiff, Wales facilities. Sean joined the PDA faculty in 2013. He holds a Bachelor’s degree in General Sciences, with a focus in Biology, from Rutgers University.

Douglas Kiehl

Eli Lilly and Company

Douglas Kiehl is a Research Advisor at Eli Lilly and Company and leads the Characterization Mass Spectrometry, Extractables/Leachables and Elemental Impurities team.  He is responsible for Lilly’s global E&L strategy supporting development and qualification of container/closure and manufacturing systems and drug delivery devices.  His team’s responsibilities include performing structural characterization of process impurities, related substances, degradation products and contaminants across development and commercialization phases for the small and large molecule portfolios.  Mr. Kiehl has over 36 years' experience with application of advanced mass spectrometry in characterization of diverse chemical entities, 24 years of which are in the Pharmaceutical Industry.  He is a member of the USP Packaging and Distribution Expert Committee, the USP Expert Panel on Biocompatibility of Materials Used in Packaging Systems, Medical Devices and Implants, the USP Expert Panel on Elastomeric Closure for Injections, the ELSIE (Extractables/Leachables Safety Information Exchange) Board of Directors, the SPIE Defense and Commercial Sensing Committee and AAPS Impurities Steering Committee.  His research interests include the development of advanced mass spectrometry based mapping and visualization techniques to enable the rapid and comprehensive characterization of highly complex mixtures of structurally diverse chemical entities.

Horst Koller

HK Packaging Consulting GmbH

Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 28 years’ industry experience. His consulting company focuses on Technical, Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active member of the WG16 for the EDQM. He is a speaker on international conferences and holds customized trainings. He has an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim, Germany.

Tim Kram

Rommelag USA, Inc.

Mr. Kram is an Engineer and pharmaceutical business development professional, and is presently the General Manager for Rommelag Engineering’s US office. For the past 15 years he worked with companies to develop aseptic product fill/finish solutions using Blow/Fill/Seal technology. This work includes container development, clinical trials, regulatory filings, combination device development, primary drug packaging, machine sizing, validation/qualification, and commercial/contract manufacturing. For ten years, he has worked to introduce temperature sensitive biotech and vaccine products to BFS technology, and has received two foundation grants for the testing of injectable vaccines with BFS technology and CPAD device development. Mr. Kram regularly consults and gives presentations to BFS operators, industry groups and regulatory organizations. In the past, Mr. Kram has worked as a process engineer, filtration specialist, project manager and service engineer. He received a B.S. in Electrical Engineering from the Missouri University of Science and Technology in 1991.

Mr. Kram is an active member in the PDA, task force member Technical Report 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology, task force member Technical Report 27 update: Pharmaceutical Package Integrity, ISPE member, AAPS member.

Stephen Langille PhD

ValSource, Inc.

Stephen Langille is a senior microbiology consultant with ValSource specializing in microbiological and visible particulate matter control strategies and solutions. He received his BS in biology from the University of Massachusetts and his PhD in microbiology from the University of Maryland. He worked for the US-FDA for 19 years serving as a Microbiology Reviewer, Branch Chief, and Director of the Center for Drug Evaluation and Research’s Division of Microbiology Assessment. He has served on several PDA interest groups and USP expert committees to help develop and improve industry and compendial standards for microbiological and particulate matter quality in injectable products.

Annie Leahy

MilliporeSigma

Annie Leahy is an MSAT Manager in the North American Manufacturing Sciences and Technology (MSAT) group within MilliporeSigma. She leads a highly technical team that ensures successful implementation and ongoing operation of customer applications across the manufacturing process. Her area of expertise focuses on virus and aseptic filtration operations as well as supporting customers during their manufacturing process to provide best practices and ensure optimal processing conditions. Annie has over 14 years of experience, which has included developing improved methods for virus spike preparations and mycoplasma retention methods as well as conducting virus and aseptic filtration applications studies at both small and large scale. She holds a BS in Biology from Dickinson College and an MS in Biotechnology from Northeastern University.

Ronald Leversee

Padagis US LLC

Ron has over 37 years of experience in pharmaceutical manufacturing with over 15 years of direct operations leadership and experience in parenteral products with specialization in Freeze Drying, Sterile Filling, Visual Inspection, and Packaging operational areas. He has experience with ophthalmic drug products, sterile vial, sterile cartridges, and pre-filled syringes. Ron is a Certified Quality Auditor through the American Society of Quality. He has spent the past 15 years presenting and instructing various Visual Inspection topics and courses through the PDA Visual Inspection Forum and Visual Inspection Training Course in both Berlin and the Training and Research Institute (TRI) in Bethesda, MD. Ron has an Associate in Applied Science Degree in Electronics Technology from Kalamazoo Valley Community College, Bachelor of Science Degree in Manufacturing Engineering and Masters of Science in Engineering Management both from Western Michigan University. He currently resides in Kalamazoo, MI.

Michael Long

AstraZeneca

Mike has over 25 years of pharma, device, and combination product and process development. He is currently a Sr. Director with AstraZeneca within their Biopharmaceuticals Development Group. Mike is active within industry including being a past member of PDA’s Science Advisory Board and has also instructed graduate courses on topics such as Data Analysis and Pharma and Device Quality Systems. Mike is a master black belt with a BS from WPI, an MS from Tufts University and doctorate from Northeastern University.

John Ludwig, PhD

Pfizer, Inc.

John leads the Medicinal Sciences organization in Pfizer R&D which includes five-line disciplines: BioMedicine Design, BioTherapeutics Pharmaceutical Sciences, Medicine Design, Pharmaceutical Sciences Small Molecule, and Global Clinical Supply.

John began his career at Burroughs Wellcome Co. in 1989 as a pharmaceutical formulator and worked on a variety of dosage forms including liquid and lyophilized parenterals, topical creams and ointments, and oral liquids. He joined Searle, Inc. in Skokie, IL in 1995 responsible for parenteral product formulation and process development, clinical manufacturing, technology transfer/validation, and the R&D microbiology function. In 2001, he transferred to Chesterfield, MO, as Site Leader for the Bioprocess and Formulation Technology organization (Pharmacia, Inc.). Following the Pfizer acquisition in 2003, John led the combined Pharmaceutical and Analytical R&D line for Pfizer Global Biologics and from 2007-2009 the Analytical R&D organization. Following the Wyeth acquisition, John led the Business Strategy, Operations, and Clinical Supply Planning function, and served as Site Director for Pfizer St. Louis Laboratories. In 2012, he became leader of BioTherapeutics Pharmaceutical Sciences. John assumed his current position in 2017.

John is active in the American Association of Pharmaceutical Scientists and the Parenteral Drug Association (PDA) Training and Research Institute. He has contributed to the development of three professional training courses and serves regularly as a course instructor for PDA.

John received a B.S. in Pharmacy and Ph.D. in Pharmaceutics from the University of Tennessee, Memphis.

John Lyons

Integrated Project Services (IPS)

John Lyons is a pharmaceutical manufacturing professional specializing in aseptic processing. He is currently a Sr. Process Engineer at IPS (Integrated Project Services) and previous positions include Senior Engineer and Partner at Sterile Technology as well as Deputy Director of Operations for OncoGenerix's parenteral manufacturing facility in Mudanjiang China. At OncoGenerix, his responsibilities included coordination and oversight of manufacturing, engineering and administration departments to facilitate operational objectives; as well as interfacing with Quality Operations to ensure compliance with internal QMS and global regulatory requirements.

As a senior engineer, John's project experience includes the complete lifecycle approach from project conceptualization, design, construction, start-up and qualification through into operation. His specialist areas include barrier isolator systems, sterilization (H2O2, steam & dry heat), sterile component handling, sterile filling of vials & syringes, lyophilization & loading systems, commissioning and qualification, and the containment of APIs and potent compounds. He holds a B.S. in Computer Engineering from the University of Scranton.

Patrick Mains

ValSource Inc.

Patrick Mains is currently a Senior Consultant at ValSource. He supports organizations in the pharmaceutical industry using his expertise in Quality Risk Management. He holds a Bachelor’s Degree in Biochemistry and Cell Biology and a certificate in Project Management from the University of California, San Diego Extension. Patrick is a Project Management Institute (PMI) certified Project Management Professional (PMP). With over 29 years of experience in the biopharma industry, Patrick has had various roles in Quality Control, Project Management, Site Compliance/Inspection Management, Quality Systems, and Global Quality at IDEC Pharmaceuticals, Biogen Idec, and Roche/Genentech.

Peter Makowenskyj

G-CON

Peter has over 19 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within 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 M. Eng in Chemical Engineering from Cornell University. He is also very active within the PDA where he currently sits on the PDA BioAB, co-Leads the Advanced Manufacturing and Applied Process Digitalization IG, and Mobile Manufacturing Task Force.

Amanda McFarland, MS

ValSource, Inc.

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 co-lead 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].

Steven R. Mendivil, BS

Amgen Inc.

Steven Mendivil is currently a part time contractor and Senior Advisor for Amgen in International Quality. He had been with Amgen for 19 years and was Executive Director of International Quality, External Affairs. He was previously head of Corporate Quality GMP & EHS and was on the ICH Q11 Expert Working Group and on the ICH Q7 Implementation Working Group. Prior to Amgen, Steve worked for 5 years at Genentech in Quality and 10 years at Syntex in Regulatory Affairs, Quality and Manufacturing. Steve also consults for a number of companies.

He was on the PDA Board of Directors as an Executive Officer and has led various external committees on GMP related topics. Steve is currently PDA’s Quality Metric /Culture Task Force leader.

He has also taught at UC Berkley extension course on Biotechnology and at USC graduate school for Regulatory Affairs.

Steve holds a BS from University of California at Davis and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.

Antonio Moreira, PhD

University of Maryland, Baltimore County

Dr. Antonio R. Moreira is a well-known and highly regarded biotechnology expert in cell culture and fermentation bioprocessing. He holds a B.S. degree in chemical engineering from the University of Porto, Portugal and M.S. and Ph.D. degrees in chemical and biochemical engineering from the University of Pennsylvania. Dr. Moreira is President of Peritus Consultants, Inc., a consulting company that specializes in the bio/pharma industries. He is Professor of Chemical, Biochemical and Environmental Engineering at the University of Maryland, Baltimore County (UMBC) where he is Vice Provost for Academic Affairs since 1997. Dr. Moreira has also been Chair of the Department of Chemical and Biochemical Engineering and Associate Dean of Engineering at UMBC.

Prior to joining UMBC, Dr. Moreira spent ten years in the private sector, in senior technical management positions with International Flavors and Fragrances, Inc. and with Schering-Plough Corporation (now Merck & Co.). At Schering-Plough, he was responsible for the fermentation process development team that brought alpha-interferon to the market under FDA and many other international regulatory agencies approval. He was also responsible for the manufacture of biologics for the US market. He worked on additional biopharmaceutical products such as gamma interferon, GM-CSF, and IL-4. Dr. Moreira consults for a number of biotechnology companies in process development, regulatory and CGMP compliance, and validation of facilities and processes. He has an active research program currently focusing on the production of biologics via mammalian cell culture, including issues related to regulatory science. He has authored or co-authored over 200 scientific publications and presentations. He received the PDA James Agalloco award in 1997 and is an Associate Editor for the PDA Journal. Dr. Moreira was the Founding President of the Chesapeake Bay Area chapter of ISPE, he is a member of the International Board of Directors of ISPE and was Chair of the Council of Biotechnology Centers of the BIO Industry Organization. He has been a member of various FDA Advisory Committees. He is a graduate of Leadership Maryland.

Kevin Mudd

Sartorius

Kevin Mudd is a Field Applications Specialist supporting Separation with Sartorius for four years in Southern California. He has 20+ years of experience in the industry such as early drug discovery and downstream processing. He is also an experienced campaign leader for downstream process development in the CDMO space. Kevin has specified expertise in Protein Based Therapies and downstream technologies.

Ryan Murray MS

ValSource, Inc.

Ryan Murray is a quality and manufacturing science Senior Consultant with ValSource, Inc. He is primarily focused in the areas of quality and regulatory compliance, facility design and control, technology transfer, process qualification, and aseptic risk management of both biologics and advanced therapy medicinal products (ATMPs). Ryan is an active member of the Parenteral Drug Associationand the International Society for Pharmaceutical Engineering (ISPE). He has a BS in biomedical science and MS in biochemistry and biophysics from Texas A&M University.

Wenzel Novak, PhD

Gerresheimer Bünde GmbH

Dr. Wenzel studied biology and did his PhD in physics at the Max-Planck-Institute for Neurochemistry in Munich. He is the head of a laboratory in a Swiss biotech-company and worked on Keratinocytes for wound healing. He also supervised project management and production for pre-sterilized syringes, he designed the manufacturing area, built up the process and quality systems and operated the start-up phase of production. He was previously a Chief-Innovation-Officer at a pharmaceutical equipment supplier where he developed new methods of sterilization and filling processes. While in the USA for two years, Dr. Wenzel established the market for cell- and gene therapy equipment. In 2018, he resumed a new role as a senior global business developer.

Matthew Ostrowski

Pfizer, Inc.

Matt was hired by Pharmacia in 1998 as a Packaging Line Coordinator in the Dry Products Department working mainly on the Blisters and Tablet lines. In 1999, Matt became an Instructor for Pharmaceutical Manufacturing where he was responsible for training, SOP documentation, and revisions for the entire Packaging Department. In 2000, Matt was promoted to the Production Coordinator in Sterile Inspection, and in 2002, he took on the role as the Inspection Supervisor which he held until 2013.

In January of 2013, Matt’s role within Pfizer changed from Supervisor to Process Technologist for the Injectable Inspection Department. In his current role, Matt’s responsibilities include process improvements, regulatory compliance, and the subject matter expert for visual inspection at the site. During this time, Matt has had a number of developmental opportunities including 2 years in the Aseptic Processing/Filling and Freeze Dry Department, and two project assignments at two separate Pfizer sites. The first was to assist with a new plant startup and product launch, and the second was at another site to develop a visual inspection process and inspection line improvement project. Along with his normal job duties, Matt is a member and Trainer for the Parenteral Drug Association teaching courses in Visual Vial Inspection and Aseptic Processing. In 2009, Matt graduated from Spring Arbor University with a Bachelor’s Degree in Business.

Diane M. Paskiet, MS

West Pharmaceutical Services, Inc.

Diane Paskiet has over 30 years of experience in the pharmaceutical industry. She is currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of pharmaceutical packaging and combination products. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is on the Product Quality Research Institute (PQRI)  Steering Committee and Chair of the Extractables and Leachables Parenteral Drug Product Working Group. Diane is also on the faculty of the Parenteral Drug Association Training Institute. She has author/co-author a number of papers and book chapters related to pharmaceutical packaging, delivery systems and combination products.

Ravi Patel

West Pharmaceutical Services, Inc.

Ravi Patel is a member of the Core Team for PDA Zero Particle Task Force representing the Elastomers Subgroup (2018-2022).  He is currently the Director of Quality Engineering and Metrology at West Pharmaceutical Services, responsible for global engineering projects, the development of automation & metrology systems, and supportting new product development & various cross-departmental initiatives. He has worked at West in various roles for over 18 years. Prior to assuming the responsibilities as Director of Quality Engineering, he served as a Project Manager for Quality Operations, a Manager of the customer complaints team for Quality Systems, a Quality Engineer responsible for validation and optimization projects, and as a Scientist within the quality organization supporting customer complaints and internal plant investigations.  Before joining West, he held the post of  an Analytical Chemist at Wyeth Ayerst responsible for developing novel quantification methods for compounds as part of a team responsible for drug metabolism and pharmacokinetics assays and as a Chemist at ViroPharma as part of research & development team responsible for design novel pathways to synthesize small molecule heterocycles intended for treatment of specific RNA viruses.

Paula Peacos, M.S.

ValSource, Inc.

Paula Peacos brings 30 years of practical industry experience as a Microbiologist. She has worked in contract manufacturing and testing organizations as well as small, mid-size and large pharmaceutical organizations.

Paula possesses extensive experience in aseptic processing, biological API/drug substance manufacturing, cell and gene therapies and nonsterile production, both clinical and commercial, as well as microbiological laboratory management.

She has also conducted numerous compliance audits internationally as a microbiological subject matter expert. She is an experienced trainer and has developed and implemented creative, customized developmental and remedial programs both in the US and abroad.

In recent years, Paula has published a number of articles, conducted technical webinars and presented at major industry meetings on topics such as data integrity, using contamination rates for trending analysis, designing and implementing robust environmental monitoring and trending programs and performing successful root cause analyses, among others.

Paula is currently employed as a Senior Consultant and Microbiological Subject Matter Expert at ValSource, Inc. She can be contacted at [email protected].

Tony Perry

SCHOTT North America, Inc.

Tony Perry has been in the glass industry for more than 20 years and has been with Schott since 2004. In his current role as the North American Director of Quality, he is responsible for supporting all production sites supplying product into the region. He is a Six Sigma Black Belt and has a degree in Mathematics from the City of London University.

Darius Pillsbury

ValSource, Inc.

Darius Pillsbury is a senior consultant at ValSource. He holds a Bachelor of Science in Chemical Engineering from Tufts University and has more than 20 years of experience working within the Biotech/Pharmaceutical industry. Darius worked on the development and validation of manufacturing processes in the Manufacturing Science and Technology group at ImClone Systems and Eli Lilly. He subsequently worked as the Director of Validation at the rare disease company, Ultragenyx, and as the Director of Quality Lifecycle Management at the cell therapy company, Adaptimmune. Darius has extensive experience in the establishment and implementation of science-driven and risk-based Control Strategies as a part of the overall process validation lifecycle approach. Darius is a member of the PDA ATMP Advisory Board and leads the PDA Cell & Gene Therapy Interest Group. Darius has many additional contributions to PDA including as an author of the PDA Technical Report 60-2 and in the current revision to TR60 Process Validation Lifecycle Approach, as well as a contributor to the PDA Annex 1 commenting team and the working groups for the standards for both the Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine and Apheresis Cell Collection.

Frank Pillsbury

Datwyler

Frank Pillsbury graduated with a BS in Mechanical Engineering from Widener University in Chester, PA. After finishing his undergraduate studies in 2000, he joined Gerresheimer Glass where he served as a Process Engineer and Project Engineer. In 2020, Frank worked for Nipro Glass as a Technical Customer Support Engineer before joining Datwyler.

Frank has over 20 years of experience in the primary parenteral packaging industry and joined Datwyler in 2022 as a Technical Key Account Manager in North America working side-by-side with Key Account and Commercial Development Managers, providing product and process support as well as technical advice concerning Datwyler’s products, services and material selection for new projects.

James Polarine MA

STERIS Corporation

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty-four 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 and the 2024 PDA Service Appreciation 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 a frequent international industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control.  He is active on the prestigious PDA’s Scientific Advisory Board (SAB).  He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection, Technical Report #88 on Microbial Deviations, and the COVID Points to Consider.  Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, ATMP, and medical device industries at the PDA and the University of Tennessee.  Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course.  Mr. Polarine is the current past President for the PDA Missouri Valley Chapter and Vice President of Membership for the IEST.  He is the PDA Chapter Council Vice Chairperson.  Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology.  He previously worked as a clinical research manager with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois.  His main hobby is storm chasing and is very active in tornado research and tornado safety. 

Eugene Polini

Eugene graduated with a Bachelor of Science degree in biology from Villanova University in Villanova, PA. After finishing his undergraduate study in 1983, he joined West Pharmaceutical Services where he served in a number of technical, quality, and customer-support roles. In 1999, Eugene graduated with a Master’s degree in business administration from St. Joseph’s University in Philadelphia. Eugene has more than 30 years of experience working with primary parenteral packaging systems from research and development to quality control to technical sales support. Eugene joined Datwyler in 2017 as a Technical Key Account Manager working side-by-side with key account and commercial development managers, focusing on technical sales management and mitigating technical issues for Datwyler’s largest clients. He is now an Independent Technology Consultant.

John Rech

WEST

Mr. Rech has ten years of experience in the pharmaceutical industry and eight years of experience in the packaging and drug delivery industry with West Pharmaceutical Services. As a senior scientist, his areas of focus were centered around customer complaint and plant investigations as well as particle analysis.  After several years in this role, he transitioned to the role of Technology Manager for Particle Testing, where he is currently leading method development and validation projects and is responsible for bringing new capabilities and technology into the West organization. 

Coralie Richard PhD

Eli Lilly and Company

Coralie Richard is the Director of Packaging Systems in Delivery and Device Connected Solutions (DDCS) at Eli Lilly and Company, Indianapolis, USA. A native from France, she came to the USA to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as a R&D scientist in a material company, she joined the primary packaging system team at Eli Lilly, supporting container closure systems development activities and container related research projects. Her contributions were recognized with two Eli Lilly Top 100 Innovator Awards and half a dozen articles and patent. In her current role she provides technical and organizational leadership in the areas of primary packaging / container closure development, secondary packaging, shipping & distribution, surface science and several related DDCS laboratories. Her global team support clinical and commercial development activities across all business units.

Lorianne Richter

ALX Oncology

Lori Richter holds a B.S. in Microbiology and over 25 years of experience in the biopharmaceutical industry. Her areas of expertise include Quality Systems, Quality Risk Management, Training, and Business Continuity Management. In her most recent role, Lori is a Sr. Director in Quality Systems at ALX Oncology based in California. She has developed many QRM training modules and delivered training to the FDA, Health Canada, and industry teams. She is an Instructor for the PDA Quality Risk Management Certificate Program. Recently, she was co-host of the podcast Risk Revolution. Lori is currently pursuing her PhD through Technological University Dublin.

Mike Sadowski

Baxter

Michael (Mike) Sadowski is a Lead Scientist leading the Sterility Assurance Community of Practice at the Baxter Healthcare Corporation. He is responsible to ensure the continued connection and strengthening of the Sterility Assurance Critical Competency in support of glboal pharmaceutical and medical device products. Mike has 30 years of experience with drug and device sterilization with a variety of sterilization modalities. In addition to participation on the Task Force for the revision of PDA TR No. 1 on Moist Heat Sterilization, he was the Chair of the Task Force for the revision of the PDA TR No. 30 on Parametric Release. Mike previously served as Treasurer, Secretary and Director on the PDA Board of Directors and member of the PDA Scientific Advisory Board and currently serves an Associate Editor for the PDA Journal and Co-Chair of AAMI WG 03 on Moist Heat Sterilization. He has successfully aligned industry and regulatory agencies to shape best practice and continues to actively publish and contribute presentations and training sessions on moist heat sterilization and parametric release. He is frequently sought as an expert speaker by global industry and regulatory Sterility Assurance professionals. Mike received his BS Degree in Microbiology from Purdue University.

Andrea Sardella PhD

Stevanato Group

Andrea holds a degree in Physics from Padua University and a Master's in Nuclear Engineering.

As a researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research. He also set up international collaborations with UWA Madison (USA) and Garching IPP (DE).

After ten years of activity in research, he moved to the industrial sector to develop optical and vision controls for industrial applications as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools.

He then joined a leading company as R&D Manager, for which he developed an innovative inspection technology for inspection machines.

Since 2008 he has been with Stevanato Group first as Pharma Inspection Product Development Manager. Here, he works to develop new automation and inspection products dedicated to the pharmaceutical customers of the Group.

Claire Scanlan

MilliporeSigma

Claire Scanlan is currently a process development scientist (PDS) with MilliporeSigma Corporation and a manager for the East Coast PDS region in the Technical and Scientific Solutions (TSS) group. Claire has been with MilliporeSigma since 2000. She has been in her current role since 2006. She assists biopharmaceutical companies with small scale normal and tangential flow and purification filtration and optimization studies. Prior to her current role, Claire was a product development engineer in Research & Development at MilliporeSigma. She developed both sterile and virus filtration products in her time in R&D.

Susan Schniepp

Regulatory Compliance Associates Inc.

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 of the BoD (2022 - 2024). 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. Sue is also 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.

John Shabushnig PhD

Insight Pharma Consulting, LLC

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 is leading 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.

Tabassam Sharif

Datwyler

Tabassam Sharif has been with Datwyler since 2018 and is currently a Manager of Regulatory Affairs. He has a Master’s degree in natural sciences and has worked within the Regulatory Affairs discipline of the pharma industry for 15 years. In his current role, Tabassam holds global responsibility for submission and update of Drug Master Files with the health authorities in order to support pharma companies in seeking regulatory approvals. He is also a member of several standardization groups, such as the Ph. Eur. experts Group 16, ISO Technical Committee 76 / WG4, and PDA Task Force on TR 73-2.

Christopher J. Smalley, MBA, MS, PhD

ValSource Inc.

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.

Kim Sobien MBA

ValSource, Inc.

Kim Sobien is a Microbiology Senior Consultant with ValSource, Inc. Her pharmaceutical industry career encompasses a breadth of Quality, Compliance, and technical experience with injectable pharmaceutical products, including parenteral pharmaceutical contract manufacturing, pre-filled syringe generics, radiopharmaceuticals, and biologics. Previously she has served as MSAT Contamination Control Lead and a GSK Fellow at GSK, Principal Sterility Assurance Engineer for PETNET Solutions, Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals (now Curia).

Kim has a BS in Microbiology from the University of Wisconsin–La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix. She is an active member of the Parenteral Drug Association (PDA) and the PDA Southeast Chapter, Co-Lead for the PDA EM/Microbiology Interest group, and a past co-chair and committee member for the PDA Pharmaceutical Microbiology Conference. She also participates on several ASTM E55.06 “Microbial and Sterility Assurance” subcommittees.

Alexis Stachowski

Charles River Laboratories

Alexis Stachowski is the Sr. Manager of the Quality Control Microbiology Department, Cell and Gene Therapy CDMO, Biologics division at Charles River Laboratories. Her team is responsible for the utilities and environmental monitoring programs, gowning certifications for the cleanrooms, and rapid-release safety testing for drug products.  Additionally, Alexis oversees the contamination control strategy for the multi-product facility. She holds a B.A. degree in Biomedical Sciences with an emphasis in Microbiology. 

Stephanie Thai

Sartorius

Ms. Thai has been with Sartorius since 2021 as a Field Application Specialist in Separations. She is responsible for providing technical guidance on filtration applications, such as sterile filtration, depth filtration, UF/DF, integrity testing, and viral filtration. Previously, she has worked in a contract-manufacturing facility, purifying microbial and mammalian proteins in a cGMP lab. She holds a B.S. degree from the University of Oklahoma in Chemical Engineering with emphasis in Biomedical Engineering.

Rahul Thakar, PhD

Datwyler

Rahul Thakar is a Technical Key Account Manager with Datwyler and has over 10 years of product development experience in pharmaceutical and chemical sciences. In his current role, Rahul consults with pharmaceutical and medical device companies on parenteral packaging solutions to develop safe and efficacious drug-delivery systems. He holds global responsibility for several key clients, where he is responsible for technical projects from the ideation to the commercialization stage. Within Datwyler, he is also leading strategic collaborations with external partners for product portfolio expansion and product innovation. Rahul was awarded his Ph.D. degree in Material Science and Analytical Chemistry from Indiana University, Bloomington where his graduate research was focused on design and microfabrication of bioanalytical devices for electroanalytical measurements.

Edward H. Trappler

Lyophilization Technology, Inc.

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.

Paul Valerio

Integrated Project Services (IPS)

More information coming soon.

Arthur Vellutato, Jr.

Veltek Associates, Inc.

Art Vellutato, Jr., is the President and CEO of Veltek Associates, Inc. (VAI is an EPA, FDA, and ISO 9001 registered facility) founded in 1981. He is also the President and Senior Consultant of Aseptic Processing, Inc., the consulting division of Veltek Associates, Inc. He is a frequent industry speaker with over 75 industry publications and is one of the leading consultants in the pharmaceutical and biotechnology industry specializing in contamination control, cleaning, disinfection, gowning and environmental monitoring. He lends over 30 years of experience that include his tenure as the V.P of Quality Assurance, the V.P of Validation, and the V.P of Manufacturing at VAI. Art Vellutato, Jr., has conducted training on Cleaning/Disinfection/Contamination Control/EM to the FDA (CDER and CBER) routinely from 2002-2017. He also conducted training for the EMEA in 2004-2012, the Kazakhstan (Russian) Regulatory Agency in 2005 and 2008, and the TGA in 2009 and 2012. Art Vellutato has trained 624,012 industry professionals to date.

Art Vellutato, Jr., is a faculty member at the Parenteral Drug Association’s Training and Research Institute (PDA TRI) for the Aseptic Processing Course (Cleaning and Disinfection Segment), the Coordinator and Faculty Trainer of the PDA TRI Cleaning and Disinfection Course, the Coordinator and Faculty Trainer of the PDA TRI Contamination Control Course, the Chairman of the PDA Cleaning and Disinfection Special Interest Group and PDA Task Force, the Chairman and Technical Writer for the PDA Task Force on Cleaning and Disinfection (TR70), and the Past President of the Delaware Valley Chapter of the PDA (after 15 years). He was named the James P. Agalloco Award – PDA Excellence in Training in 2011, and the 2017 PDA Gordon Personas Award. Art Vellutato, Jr., is also a Faculty Member United States Pharmacopeia (USP) for USP <797> Workshops and a Faculty Trainer for the Aseptic Processing course at Aseptic Training Institute – Clayton, NC.

James Vesper PhD, MPH

ValSource, Inc.

James Vesper designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries. Beginning in March 2017, he became Director, ValSource Learning Solutions after establishing and being president of the firm, LearningPlus, Inc. At ValSource, he leads a business unit that provides innovative learning solutions to pharma firms world-wide, leveraging the capabilities and expertise of ValSource consultants. He has had more than 35 years experience in the pharmaceutical industry.

Dr. Vesper has written six books, including Root Cause Investigations for CAPA
(2020) and multiple technical articles. His 5thEdition of GMP in Practice, written with Tim
Sandle published in 2016 by PDA/DHI. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has been a mentor on six of the WHO’s unique learning program, Pharmaceutical Cold Chain Management on Wheels. He has trained health authority inspectors through WHO and PIC/S in US, Brazil, Taiwan, London, China, Greece, and Turkey.

James Wamsley

ValSource, Inc.

James Wamsley has nearly 20 years experience in aseptic and low-bioburden operations, quality, training, contamination control and environmental monitoring. He spent more than 11 years at PDA's Training and Research Institute responsible for management and delivery of laboratory training courses. He has since spent time in roles with progressively more responsibility including aseptic performance improvement for clinical drug product manufacturing, development lead for contamination control and EM program at a new high-throughput SVP manufacturing facility, and as site lead for contamination control and environmental monitoring at clinical/commercial vaccine and gene therapy drug substance and drug product site.

James earned his Bachelor of Science in Biological Sciences from the University of Maryland, Baltimore County and is currently a Microbiology Consultant for ValSource, Inc.

Brent Watkins

Veltek Associates, Inc.

Brent Watkins is currently the South East Technical Manager for Veltek Associates, Inc., providing contamination control products and services to the pharmaceutical and biotech industries. Prior to Veltek, Brent worked for Abbott Laboratories in small volume injectable operations in a variety of supervisory roles. In addition to his responsibilities at Veltek, he is a course instructor for aseptic processing related topics at the Parenteral Drug Association, was a member of the PDA task force for Technical Report 70 (Fundamentals of Cleaning and Disinfection), and currently serves as the Vice Chair of the Education Advisory Board. Brent graduated from Wake Forest University in 1995 with a Bachelor’s degree in Chemistry and lives near Rocky Mount, NC with his wife, Rebecca, and son, Jacob.

Rob Weaver

Weaver Consulting LLC

Founded in 2003, Weaver Consulting is a two-person enterprise comprised of Tom Weaver and Rob Weaver. They are quality and operations improvement consultants who focus exclusively on root cause analysis. With a worldwide client base, they have helped organizations across a multitude of industries, including pharmaceutical, medical device, aerospace, defense, financial services, food & beverage, consumer products, automotive, telecommunications, semiconductors, and many more, successfully implement their Root Cause Investigation for CAPA methodology. Both Tom and Rob held titles of Vice President in their respective careers before joining the firm, Tom with Baxter Healthcare and Rob with Wells Fargo & Company.

Anne Weeks

EMD Millipore

Anne has been a Regional Marketing Manager with EMD Millipore since 2011. Previous to her marketing role, she worked in as a senior scientist in a pharmaceutical QC Microbiology laboratory. Anne has experience in Validation, Environmental Monitoring programs, as well as Isolator technology. Anne has previously worked with contract manufacturing sites as an internal quality resource for Environmental Monitoring and continues to support clients in establishing programs and troubleshooting challenges. In Anne’s current role in Marketing, her focus is on Environmental Monitoring Media Fill testing and Services, and is able to apply her pharmaceutical experience to much of her work that involves compliance with regulatory aspects as well as interpretation of guidances and technical reports.

Fubin Wu

GessNet™

Fubin Wu is the Co-Founder and President of GessNet™, providing consulting and software tools for medical device and drug device combination product risk management, safety assurance cases, cybersecurity, and reliability.

Having served for over 30 companies, Fubin has experience with a broad range of medical products including drug delivery combination products, infusion pumps, insulin pumps, on-body injectors, emergency use injectors, mobile medical applications, digital solutions, implantable devices, cardiovascular devices, robotic surgery devices, IVDs, remote monitoring systems, and blood management systems. He is a member of multiple AAMI working groups including infusion devices, combination products, cybersecurity, and software. He also teaches public courses on medical device and combination product risk management, safety assurance cases, cybersecurity, and software reliability.

Prior to GessNet™, Fubin worked for Medtronic, Hospira, and Haemonetics in the roles of engineer, manager, and director, and spent over 16 years on hardware/software quality and reliability engineering, risk management, and quality management systems.

Fubin has an MS degree in Electrical and Computer Engineering from Oregon Health & Science University (OHSU) and was a software developer at Intel before joining the medical device industry.

Sheba S. Zaman

Novatek International

Sheba Zaman has been serving in a technical role at Novatek International for over 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 Contamination Control, Environmental and Utility Monitoring, Cleaning Validation, LIMS, Stability 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 process mapping, establishing procedures, work instructions, validation scripts and training programs. Key areas of expertise include Data Integrity, Process Improvement, Data Analysis/Trending, regulatory compliance, software Implementation and optimization in a regulated environment. She also teaches PDA tri/ISPE/KENX courses for various contamination control topics and formerly served as the President of Parenteral Drug Association’s (PDA) Southern California Chapter.