Meet our Expert Advisors

Julie is an EO Sterilization Expert Advisor at Sterigenics. With 30 years of expertise in the industry, she has held positions such as Laboratory Supervisor, Validation Coordinator, and Business Support Manager. For 15 years, Julie has been an active member of the Association of British Healthcare Industries Sterilization and Microbiology workgroup, London (UK). She is also a member of CH/194 – Biological evaluation of medical devices. Julie organizes training sessions for customers, as well as gives presentations during the sessions.

Education
HNC – Applied Biology. Her industry-specific advanced training includes 10 credits at advanced Diploma / MSc level for completing Module 17 of the Pharmaceutical Industry Advanced Training Program “Sterilization of Medical Devices” run by PIAT / Manchester University and an Internal QMS Auditor Training Course operated by JPD

Expertise
Ethylene Oxide Sterilization Validations According to ISO 11135 Including Process Definition, Product Adoption Studies, and Parametric Release; Laboratory Testing Services Associated with EO Sterilization Validation and Routine Control; EO Product Residual Validations According to ISO 10993-7; BI Sterility Failure Investigations

Dr. Campbell is a Board Certified Diplomate of the American Board of Toxicology. She has over 20 years of experience working in toxicological research, 20 years of applied analytical chemistry experience, 14 years of experience in pharmaceutical research (including both clinical and nonclinical), and 12 years of experience as a bench chemist. Her particular areas of interest include medical device and pharmaceutical nonclinical program design and implementation, investigative toxicology, risk assessment of extractable & leachable compounds from medical devices, and regulatory interactions.

Dr. Campbell received her Ph.D. in Pharmacology and Toxicology from the College of Pharmacy at the University of Utah. She then completed a Clinical Pharmacology Fellowship under the School of Medicine in the Department of Pediatrics, Division of Clinical Pharmacology and Clinical Trials Office at the University of Utah. Her fellowship research involved study design and IRB/IACUC protocol development for translational, preclinical, and clinical research. Most her research was undertaken in special populations and involved clinical toxicology, personalized medicine, pharmacogenomics, drug-drug interactions, pharmacokinetics/toxicokinetics, pharmacodynamics, pharmaceutical drug formulation, and clinical decision making studies. Several peer-reviewed scientific articles and conference papers resulted from this work. Dr. Campbell has also authored three book chapters. She has obtained vast knowledge of nonclinical GLP regulatory requirements and clinical GCP regulatory requirements for human subject research, healthcare compliance, and FDA bioassay analytical method development for investigational new drugs (INDs). Dr. Campbell is also currently eligible to sit for the American Board of Clinical Pharmacology exam.

Dr. Campbell’s experiences include dissertational research conducted at the Center for Human Toxicology which involved the development of a novel hair biomarker of toxic tobacco smoke exposure utilizing mass spectrometry method development and histopathology. During this time, she also obtained project funding and was the Principle Investigator of a National Children’s Study Innovative Research Grant which addressed toxic tobacco exposure in children. Previous to her graduate studies, she was an Analytical Chemist in industry for seven years. As an Analytical Chemist, she prepared and analyzed industrial hygiene and environmental samples for over 60 different analytes in various types of matrices for commercial clients as well as for contracts under EPA, NIOSH, OSHA, and DOD, among others.

Griffin Cammack has worked at Nelson Labs for over 8 years, specializing in cleaning, disinfection, and sterilization validations of reusable medical devices. His current role as Expert Technical Consultant at Nelson Labs involves providing assessments and justifications for reusable medical device validations for manufacturers, such as master product (worst-case device) determinations, test method justifications, test failure risk assessments, reprocessing validation report summaries, and gap assessments. He presents at Nelson Labs seminars across the U.S.

Griffin graduated from Brigham Young University (BYU) – Idaho with a bachelor’s degree in biology and started at Nelson Labs in 2014. By actively participating in the development of guidance documents and standards as a member of the American Association of Medical Instrumentation (AAMI) and the American Standard Test Methods (ASTM), he has remained up to date with the current industry recommendations.

Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two CROs.

From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas (US), working on hydrogenated triblock co-polymers.

Since 2001, Piet has held the position of Scientific Director at Nelson Labs Europe where he develops analytical methods and protocols for both extractables and leachables studies for the pharmaceutical and medical industries.

Piet oversees all laboratory operations at Nelson Labs Europe and is also giving support to business development and R&D.

Bart joined Sterigenics beginning of 2005 and currently serves as Technical Director, Radiation. During his career with Sterigenics, Bart has performed IQ/OQ validation of Gamma and Electron beam irradiators, and designed and executed process definition programs (establishing sterilization and maximum acceptable dose) as well as PQ for customers—specifically those in the biologics and pharmaceutical industries. By invitation, Bart speaks at Nelson Labs (a Sotera Health company) training sessions, Sterigenics training sessions, customer training sessions, and industry events such as ICARST 2017, ACP 2017 and, most recently, the CPhI 2018 conference. He is actively involved in industry committees, task forces, and working groups. As a working group member, Bart represents Belgium on ISO TC 198 WG 2 Radiation Sterilization. He is also a member of ASTM E61 and a member and past secretary of the Irradiation Panel.

Education
PhD in Nuclear and Solid State Physics, Leuven University (Belgium)

Expertise
Radiation Sterilization

Aaron DeMent has been with Sterigenics for over 20 years and currently serves as Vice President of Sterilization Technologies for Sterigenics. In this capacity he oversees the Expert Advisory services group as well as being responsible for R&D including the development of new sterilization technologies. Prior to his current position, he has held a variety of positions including VP of Global QA, Director of QA, GM, QA Manager, R&D Principal Sterilization Scientist, Sterilization Manager, Corporate Training Manager and QA/ Sterilization Consultant.

Aaron has 28 years of experience in Medical Device, Pharmaceutical and Biologic Industries, much of it international. His primary experience is in sterilization where he has worked in all aspects of the business including QA, Operations, R&D and Distribution.

Annick boasts over 15 years of extensive expertise in the fields of ethylene oxide sterilization, quality management, and pharmaceutical manufacturing. In her role as Technical Director, Chemical sterilization Pharma, Annick leads the Ethylene Oxide (EO) sterilization projects at numerous Sterigenics facilities and supports the sites as the technical expert with pharmaceutical project responsibility. She’s also supporting the development and validation of new technologies like NO₂. Renowned for her seasoned speaking engagements, Annick is a frequent presenter at significant industry conferences such as CPhI, and she holds acclaim as a recognized trainer by the Parenteral Drug Association (PDA). Her contributions extend beyond the podium, as she has also contributed to various technical journals. Annick’s presentations consistently delve into innovative and tailored solutions for the terminal sterilization of pharmaceuticals. Recognizing the evolving landscape of pharmaceutical regulations, Annick has recently augmented her skill set by acquiring competencies in Regulatory Affairs.

Education
B.Sc. Liège (Belgium), DES Total Quality from Faculté Polytechnique Mons (Belgium), Management of Pharmaceutical Quality Systems from the ECA Academy, Regulatory Affairs certificate Liège-Namur University

Certifications
Certified Trainer, EO Sterilization Validation, Quality auditor

Expertise
EO and NO2 Sterilization Validation of Medical Devices and Pharma Applications (API, drug products, Prefilled devices), Cycle Design and Development, EO Residues, Quality management systems, Regulatory Affairs of health care products

Gregory is a Technical Director, EO for EMEAA with Sterigenics. He is responsible for the development of new cycles, customer validation, and R&D projects. He is a leader in validation, development, and cycle design and improvements in the EMEAA regions. Gregory is an active trainer who enjoys sharing his knowledge with others through formal seminars at trade shows, as well as informal customer training. He has been published in Medical Design & Outsourcing and Med Device Online and holds a patent EP 638909A1: “Process for preparing sterile Brinzolamide” (European patent application, 18/09/2013, F. Porstmann, J. Ondracek, K-T, Van Van, G. Grams).

Gregory is also a member of ISO TC198 – WG1 for EO sterilization representing Belgium in the ISO committee.

Education
Master in Industrial Chemistry, Engineering High School, Liège (Belgium); Business Administration Certification, Cambridge (UK)

Expertise
Ethylene Oxide Sterilization Validation of Medical Devices, Cycle Development, Medical Device Consulting, Gas Chromatography Method Validation, Failure Investigations

Jennifer Gygi is an Expert Technical Consultant at Nelson Laboratories; a microbiological testing company specializing in improving the quality of life by ensuring medical products are safe, sterile, and functional. Jennifer has over 26 years of laboratory experience at Nelson Labs. She has worked in the Microbiology, Bioburden, Organism IDs, Packaging and QC Validations groups. As one of the original members of the packaging group, Jennifer has unique insights into how the packaging tests work, including pitfalls and failure points. Jennifer was also involved with all the packaging validations, new methods and documents in her 14 years in the group.

In addition to packaging expertise, Jennifer has a sound understanding of Microbiology tests and concepts and was certified as both a Registered Microbiolgist and Specialist Microbiologist by the American Society for Microbiology (ASM). Jennifer serves on American Standards and Testing Materials (ASTM) packaging committees and gives frequent presentations on packaging test methodology, selection and validation.

Erik’s focus—and passion—is innovation & compliance. Erik is the Sr. Director, New Sterilization Technological Services and has +15 years of experience in the Pharmaceutical and Medical Industry in different domains such as Quality Control/Assurance, Qualified Person, Lean Production, Laboratory, Regulatory Affairs and Business Development in several companies. Focus on people and project management skills with certification of lean six sigma black belt. Quality systems include ISO 13485, ISO 10993, ISO 9001, ISO 17025, EU/FDA GMP and GLP. He is a member of ISPE, PDA, Board Member of the Royal BE Association of Qualified Persons and Kilmer Modality Team Community.

Education
M. Sc and Ph.D. in Pharmaceutical Sciences (KULeuven – Belgium), M.Sc. in Industrial Pharmaceutical Sciences (UGent, UAntwerpen, VUBrussel, KULeuven – Belgium)

Expertise
Research & Development and RA/QA Expert

Shiri Hechter is an organic chemist. She received her master’s degree in organic chemistry from Tel-Aviv University in 2005.

She began her career at Gibraltar Labs in 2006. She started as a Chemistry Group Leader in the analytical chemistry department.  After two years, Shari was promoted to the QA department as a Quality Assurance deputy — with a focus on analytical chemistry.

During her time in QA, Shiri completed CQA (Certified Quality Auditor) and CSSGB (Certified Six Sigma Green Belt) training with the American Society of Quality (ASQ), and currently holds both certifications.

In 2017, Shiri moved back into operations, as the Chemistry Department Manager. As the leader of the analytical chemistry department, Shiri oversees all analytical testing, and fills the role as the main subject matter expert for analytical testing — giving support to the technical service teams.

After completing her Master’s Degree in Industrial Pharmacy, Marie-Pierre started her career as a Process Supervisor in the production of vaccines and then move to a role as a Clinical Trial Manager. After a couple of years in the Operations part of the business, she once again continued her education with a Master’s Degree in Management in order to take a role in Business Development. Marie-Pierre started at Sterigenics seven years ago as the Responsible Site QA for an EO facility as well as executing the role of Qualified Person per EU regulations for pharmaceutical products. Marie-Pierre assumed the role of RA/QA Director for EMEAA three years ago and ensures the QA oversight of eleven EMEAA facilities for both RADIATION and GAS technologies. Marie-Pierre is also a Pharmaceutical Quality Systems Auditor, and she is listed as an EU-registered Qualified Person and Lead GMP and ISO 13485 auditor.

Expertise
Deep knowledge in both EU regulatory requirements as well as global sterilization requirements

In March 2017, Dr. Dennis Jenke became Principal Consultant for Nelson Labs Europe.

In this role, Dr. Jenke supports the customers of Nelson Labs Europe in the discussion of general principles, concepts, tactics, and/or strategy related to chemical characterization and qualification of materials, components, and systems used in these industries. Furthermore, as Principal Consultant, Dr. Jenke can provide Nelson Labs Europe clients with science-based expert insights into the design, justification, interpretation, and regulatory requirements of the related chemical assessment studies and programs.

Dr. Jenke is also the founder of Triad Scientific Solutions LLC, a consultant-based technical service organization that provides the pharmaceutical, cosmetic, food, and related industries with integrated, science-based, and practical solutions to suitability for use challenges for packaging, manufacturing components and systems, and devices. Dr. Jenke was a Distinguished Scientist at Baxter Health Care Corporation for more than three decades where his primary responsibility involved the assessment of material/product compatibility, including extractables and leachables testing. He has published extensively in the areas of analytical chemistry, material/solution compatibility, and extractables and leachables. Dr. Jenke serves as an expert reviewer for numerous pharmaceutical and analytical journals and is a member of several industry groups such as USP, PQRI, AAMI/ISO, and ELSIE.

Jeni Lauer is a seasoned scientist with extensive expertise in protein biochemistry, peptide chemistry, cell biology, and physiology. Her academic work includes 15 years designing and synthesizing peptides and mini-proteins with defined 3D architecture. With a focus on cancer biology, this work helped map cell-binding sites to extracellular matrix proteins and to better understand the mechanism of collagen hydrolysis. Expanding on this work, she spent more than a decade studying protein backbone dynamics to better understand the structure-function relationships in nuclear receptors and proteins involved in intracellular trafficking. Jeni has contributed to 75 peer-reviewed publications and book chapters. Currently she works as a biocompatibility expert with the Expert Advisory Services team at Nelson Labs, where she utilizes her chemistry, biochemistry, and cell-biology experience, as well as academic-research acumen, to create solutions for test sponsors/customers.

Steve has over 25 years of quality and regulatory compliance related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. He served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA.

Steve is an expert in Current Good Manufacturing Practices (CGMP) compliance related matters and has significant experience with other GxP quality compliance and regulatory issues (Ex: GCP and PV).

Steve is currently the Executive Principal Consultant, Pharmaceuticals and Biologics for Regulatory Compliance Associates (RCA). Prior to RCA he was the principal consultant/owner for Lynn Consulting, LLC, which provided expert GxP consulting services to the life sciences industry.

Before entering the consulting world, Steve was the Global Head of Group (Corporate) Compliance and Audit at Novartis AG. In this role Steve led the corporate compliance and audit functions for Novartis. Prior to joining Novartis, Steve was the inaugural Vice President of Global Quality Compliance at Mylan, Inc. in Canonsburg, PA.

Kevin is the Technical Director of Radiation Physics and holds corporate responsibility for measurement and calculation of absorbed dose associated with the radiation treatment of the product, such as sterilization of health care instruments. Over his 30-year career, Kevin has been published many times. He has experience in radiation physics and radiation dosimetry within a highly technical industry. He is actively involved in numerous industry committees, task forces, and working groups. As a working group member, Kevin represents Canada on ISO TC 198 WG2 Radiation Sterilization. He is also a member of the AAMI Sterilization Standards Committee, WG2 – Radiation Sterilization and ASTM Subcommittee E61 Dosimetry for Radiation Processing, and is Chair or Co-chair of ISO/ASTM 51707 Estimating Uncertainties, 51275 Radiochromic Film, E2232 Mathematical Methods. Kevin is a former President/VP, of the Radiation Process Simulation and Modelling User Group (2002 – 2010).

Education
BSc Honours Physics, University of Western Ontario (London)

Expertise
Radiation Sterilization, Radiation Dosimetry, Mathematical Modelling, Hockey

Microbiologist | Problem-Solver | Speaker

As an Expert Advisor focused on Ethylene Oxide (EO), Nicole is responsible for leading and overseeing diverse, comprehensive analytical studies on medical device and pharmaceutical-based products. She is well versed in ISO and their requirements. Prior to joining Sterigenics, Nicole was a Sterility Assurance Specialist with Cardinal Health and a Microbiologist with Baxter International Inc. A knowledgeable speaker, Nicole is often invited to present EO sterilization topics at seminars offered by Sterigenics.

Education
B.S. in Microbiology, University of Iowa (Iowa) 

Expertise
Ethylene Oxide Sterilization Validation and Requalification, Relative Resistance Evaluation Including Product Adoption, EO Single Lot Batch Releases, Parametric Release, Process Equivalency, Supplier Management of Contract Sterilizer

Alpa Patel is a certified microbiologist and has been part of the medical device industry for 18 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a principal scientist at Nelson, involves overseeing test method validations for reprocessing, writing standard test protocols (STP) and standard operating procedures (SOP) for reprocessing and other internal and globally related documents, providing technical consulting for the Reprocessing sections at Nelson Laboratories in Salt Lake City and globally.

As a member and collaborator with the American Standard Test Methods (ASTM), American Association of Tissue Banks (AATB) and American Association of Medical Instrumentation (AAMI) and International Organization for Standardization (ISO), she plays an active role, in concert with the FDA and regulatory committees, in developing standards, collaborating and voting on changes to those standards.

Simon currently serves as Radiation Technical Advisor. He has spent 6 years as a Quality Assurance and Regulatory Affairs Associate within the Laval Gamma Centre of Excellence (GCE) in Canada. He has experience in IQ/OQ/PQ validation of gamma irradiators. Simon is a Radiation Safety Officer and an experienced radiation safety trainer. He has a master’s in physics from the University of Montreal with a specialization in Medical Physics and has broad experience in dose mapping, radiation dosimetry, radiation safety and training.

Education
M. Sc. in medical physics & B. Sc. in physics, University of Montreal (Canada)

Expertise
Radiation physics & sterilization

Rupinder is a Microbiologist with a BSc in Microbiology from Rutgers University, a Masters in English, a BSc in Botany, Zoology and Chemistry from Punjab University, India and a Bachelor of Science in Education from GNDU University, Punjab India.

She joined Gibraltar Laboratories in May of 2009 as a Microbiologist. In January of 2011, she was promoted to the Quality Assurance Department and as deputy in QA (micro) was responsible for reviewing all test reports associated with Microbiology, Molecular Biology, Virology, and Sterilization work. In December of 2017, Rupinder was promoted to a QA Manager position.

Recently she transitioned back into the lab in June of 2019, as a Senior Lab Operations Microbiology Manager.  She is responsible for overseeing Sterility, Media Prep Lab, Molecular Bio, Virology, Environmental Monitoring and Bioburden departments.

Dr. Räägel is a globally recognized expert in medical device biocompatibility. She has extensive expertise in writing biological evaluations and assessments for regulatory submissions. These documents focus on using a risk-based approach in defining the path to evaluating medical devices, with US FDA and EU regulatory bodies as the primary audience. She works closely with medical device manufacturers and global regulatory bodies on a daily basis. Thanks to her distinguished academic background with over ten years of experience in scientific research, she has a broad knowledge of biological systems and the analytical procedures used to evaluate biocompatibility in vitro and in vivo. She also has over two years of medical device experience managing validation work for regulatory acceptance and is a member of several ISO 10993 work committees.

Dr. Räägel received her PhD in molecular cell biology, with research focusing on cell migration, polarity, and targeted delivery of bioactive therapeutics. Her postdoctoral research project aimed at discovering the molecular mechanisms behind organ development and structural assembly using in vitro techniques and animal models. Her successful academic career was rewarded by an Alexander von Humboldt Fellowship in Germany, and later by a Marie Curie Fellowship, distinctions competitive on a global scale. Since that time, her experience has been wide-ranging including leadership and involvement in a variety of special projects relevant to biocompatibility of medical devices and their materials.

In his role of Expert Advisor, Stefan leads Ethylene Oxide (EO) sterilization projects in a number of facilities in EMEAA. He also supports the facilities as a technical expert. An experienced trainer, Stefan gives training on EO sterilization to customers and notified bodies. He has also co-authored several peer-reviewed publications in the area of plant biology and a peer-reviewed study on the reduction of PCR-amplifiable DNA by EO treatment of forensic consumables.

Education
PhD in Biology and Diploma Degree in Biology, both from Philipps University of Marburg (Germany)

Expertise
Ethylene Oxide Sterilization Validation, Product Adoption, Single Lot Release Processing, Validation of Reduction of DNA Contamination on Products for Forensic Use

Chad Rhodes is an experienced industry leader with over 25 years of radiation and sterilization expertise. In his role as a Segment Leader, Chad works with our customers to develop new sterilization processes and applications that increase the usage of electron beam sterilization technology and drive both process and supply chain efficiencies.

Mr. Rhodes is adept at translating complex technical information into an applicable format that supports the advancement of accelerator technologies that deliver value to our customers. He is a leader on three process patents for unique processing applications utilizing electron beam accelerator technologies. Additionally, he is a member of the International Society of Pharmaceutical Engineers (ISPE).

As a featured author and speaker, Mr. Rhodes holds specific expertise in the medical, pharmaceutical, and industrial markets for the radiation processing industry. In his personal life he is passionate about spending time with his family, including his six children and three grandchildren.

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles on biocompatibility topics.

He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) TC 194 and 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods, and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.

Leader | Industry Expert | Author

John is the Vice President of Technical Services and holds global corporate responsibility for all technical areas of radiation processing. He holds 30+ years of experience in irradiator operations, radiation safety, IQ/OQ validation of Gamma and Electron beam irradiators, radiation dosimetry, and process qualification. John is active in industry and professional associations such as Gamma Industry Processing Alliance (GIPA) and ASTM  Committee E61 on Radiation Processing. He is a sought-after industry expert who has contributed to publications, papers, and books.

Education
BS in Physics, Rensselaer Polytechnic Institute (New York)

Expertise
Radiation Sterilization, Validation and Safety

Susan has over 40 years of quality-assurance experience in the pharmaceutical industry. She has earned several awards from the Parenteral Drug Association (PDA), including Distinguished Author Award, Distinguished Service Award, and Gordon Personeus Award. Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011 to 2013 and from 2016 to 2019 and is the immediate past chair of the board of directors. She has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She writes a column for Pharmaceutical Technology and BioPharm International every other month and also serves on both magazines’ editorial advisory boards. She is currently chairing the PDA’s ANSI standard on quality culture.

Catherine is a Radiation Technical Advisor, at Sterigenics. With 11 years of expertise in the pharmaceutical and medical device industry, she has held positions such as Quality Control Scientist, Quality Assurance Specialist and Quality Assurance Manager. Catherine has many years of pharmaceutical and medical industry knowledge having worked for companies such as Boehringer Ingelheim and Merck GmbH; including both small and large molecule pharmaceutical manufacturing.

Education
B.S. Pharmaceutical Sciences from The Ohio State University (Columbus, OH).

Expertise
Quality Assurance for Pharma and Medical Device industries, Analytical Testing of APIs and drug product excipients.

Zabrina is a Radiation Technical Director. She has direct accountability for overseeing diverse, comprehensive analytical studies on medical devices, pharmaceutical, and tissue-based products. She currently works as the primary coordinator and consultant on radiation sterilization projects. Zabrina began her career at Nelson Labs (a Sotera Health company), which performs microbiology and sterility testing. She developed testing methods for medical devices, pharmaceutical products, and human and animal tissue. Zabrina is a lecturer on radiation topics and validation methods. Zabrina is also a member of numerous professional and industry associations including AAMI Faculty, ASTM International, American Association of Tissue Banks (AATB), and the Parenteral Drug Association (PDA).

Education
BS Genetics Major, Chemistry Minor at University of Illinois (Chicago), and BA Criminal Behavior Major, Law Minor from the University of Nevada (Nevada)

Certifications
Medical Device Directive and CE Mark

Expertise
Radiation Sterilization Validation, Radiation Sterilization Dose Audit, Radiation Sterilization Product Adoption, Method 2 Sterilization Validation Development, Test Methodologies, Product Evaluation, Family Development, Failure Investigation

Audrey Turley has 22 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert having performed all the in vitro tests offered at Nelson Laboratories, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM and NIH methods), and genotoxicity (Ames and chromosome aberration). Audrey also has experience performing, consulting and training on bioburden, microbial IDs, sterility and bacteristasis/fungistasis testing. She trains staff within the biocompatibility department and works on a company- wide level to trouble shoot problems.

Audrey worked on the team responsible for the development of the in vitro mammalian chromosomal aberration assay at Nelson Laboratories. This included connecting with industry experts who developed the assay under OECD. She is also one of the leads at Nelson Laboratories for developing the in vitro skin irritation assay for medical devices. Audrey is collaborating with ISO members around the world to approve a procedure for round robin testing in order for this assay to gain acceptance by regulatory bodies in Europe and then in the United States.

Audrey is an active committee member of many working groups with the Association for the Advancement of Medical Instrumentation (AAMI).

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe in 2013 as Study Director Extractables & Leachables, focusing on parenteral applications, and in 2014, she became responsible for the chemical characterization testing of medical devices (ISO 10993-18). In 2016, she became Department Head Pharma Services at Nelson Labs Europe. The main focus of this team is identifying organic impurities in drug products as well as in-use stability for drug-device combinations. In 2017, the scope expanded and now she is also responsible for all microbiological as well as in vitro toxicological testing and cleaning validations at Nelson Labs Europe. Lise actively speaks about extractables and leachables, material characterization of medical devices, impurities, and drug-device interactions at conferences and workshops. She is also one of the key lecturers at the Impurities Forum organized by ECA.

Richard holds more than 20 years of experience leveraging a unique blend of business, manufacturing and information technology.His strong communication, organizational and technical skills make him an ideal expert to answer your questions. Richard holds a BASc Mechanical Engineering from the University of Waterloo.

Martell Winters is a specialist microbiologist (NRCM) and a radiation specialist (AAMI). He has been at Nelson Labs for 24 years and spent his earlier years working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue, and pharmaceutical products.

He is a participating member of many AAMI sterilization standards working groups and is the US representative to ISO for three working groups. He is the Convenor of ISO WG 16 on vaporized hydrogen peroxide sterilization. Martell’s participation on domestic and international committees allows him to bring a unique perspective to the industry by elevating the standards for safeguarding global health.