Fred Ohsiek, who earned his BS in Chemistry from University of South Florida, resides in the NC RDU area. He has 25 plus years of validation experience as an FTE and Consultant, while specializing in cleaning validation.

He has been fortunate to work for 7 major pharmaceuticals (Catalent, AstraZeneca, Boehringer Ingelheim, Teva, Astellas, Bayer, and Novo Nordisk) where he was considered the cleaning validation SME in most of his roles. Working with various routes of administration (OSD, parenteral, topical, and softgels) in green and brown field small and large molecule manufacturing projects has provided Fred with a very broad range of experience.

Fred also obtained “cleaning chemistry” experience while working as a Sr Global Technical Manager at Ecolab (Life Science division).

As Associate Director of Cleaning Validation at Eliquent Life Sciences, he and his team support industry by authoring tailored justifications, reducing the validation footprint via risk assessments, creating startup CV programs, remediating legacy processes, and increasing manufacturing capability.

He was one of the authors of the ISPE Cleaning Validation Lifecycle – Application, Methods, and Controls guidance, and he regularly presents at conferences nationally and globally.

Varadharaj Vijayakumar is an Associate Director (Aseptic Processing) at Wuxi Biologics, bringing over 16 years of experience in the Pharma/BioPharma industry. Specializing in pharmaceutical technical operations, his expertise encompasses aseptic processing, sterility assurance, manufacturing technology, process validation, failure investigations, troubleshooting, continuous improvement, and Lyophilization Technology. He is also highly skilled in Isolators with VHP cycle developments and resolving complex technical, regulatory, and GMP issues.

 Throughout his career, Varadharaj has successfully managed GMP inspections and audits, addressing inspectional observations from leading regulatory bodies such as WHO, USFDA, UK-MHRA, ANVISA, INVIMA, and CDSCO. His broad experience includes working with well-established pharmaceutical and biologics manufacturers, including WUXI Biologics Germany, Franz Ziel GmbH Germany, Pfizer India, Dr. Reddy's Laboratories Ltd, Emcure Pharmaceuticals (Oncology Division), and Biocon Biologics (India) Ltd.

Varadharaj has played an integral role in numerous projects, from concept design (greenfield and brownfield) to the successful commercialization of products and their continuous improvement. He has led teams in tackling operational and regulatory challenges, including regulatory reviews, production output, validation constraints, and addressing inspectional observations.

A registered pharmacist with a postgraduate degree in Pharmaceutical Sciences, Varadharaj is an active member of professional organizations such as ISPE, PDA, GENAP Summit, Pharma Days, Innovotrix, TBM, Speak Pharma, R&Y, Conferenzia, and Lyophilization World.

In addition to his industry work, Varadharaj contributes to the field by publishing technical articles, teaching students, and delivering webinars and training sessions on topics like qualification and validation for aseptic processing. His international experience, which spans countries such as Russia, the UK, the USA, Ireland, India, and Germany, has allowed him to train operational personnel through both short-term assignments and long-term global engagements.

Cecilia Pierobon is a graduate Chemical Engineer from the National University in Tucuman, Argentina and has a master’s degree in Engineering Management from the University of Applied Sciences in Biberach, Germany. She currently holds the position of Technical Services Manager at STERIS Life Sciences and is based in Germany. In this position, she provides technical support on cleaning validation and contamination control.

Cecilia has over four years of experience in the industry. Over those years she has worked in the qualification of pharmaceutical equipment for production and laboratory environments, as part of the Quality GMP Compliance Team and as Project Manager in Supply Chain packaging serialization.

Thomas Altmann has 22 years’ experience in cleaning chemistry, cleaning process, cleaning validation, and regulatory compliance. As technical consultant and validation manager, he provides technical consultation on cleaning and sanitisation process optimisation for pharmaceutical, API, biotechnology, and personal care manufacturers in Europe, Middle East, Asia Pacific, North America, and Africa. In his role, Thomas is a subject matter expert in cleaning validation for product contact surfaces across all types of pharmaceutical and personal care production equipment.

Morcos Loka is Quality Senior Manager Biologics f&f and New Projects and previously Training Manager & GMP Advisor at Minapharm. Over 25+ years, Morcos played different production and quality roles in pharmaceutical & biopharmaceutical industry. His experience includes manufacture of sterile and non-sterile products, handling of regulatory and customer audits, conducting internal & supplier audits, GMP gap analysis, GMP training, GMP consultation, establishing quality management system, management review, quality metrics, establishing quality risk management system, QRM studies including manufacturing of HPAPIs in shared facilities and design of pharmaceutical and biopharmaceutical manufacturing facilities. Morcos has Master in Business Administration (MBA), B.Sc. (Hons) in Pharmaceutical Sciences, two postgraduate diplomas in Total Quality Management (TQM) and Train of Trainer (ToT) and four professional certificates: ASQ Certified Manager of Quality / Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA) & Certified Pharmaceutical GMP Professional (CPGP) and ISPE Certified Pharmaceutical Industry Professional (CPIP).Morcos is ASQ, ISPE and PDA member. He participated in different ISPE and PDA publications and as a speaker at different Vonlanthen, Etapa Pharma, Speak-Pharma, IVT, ECA, PDA and ISPE pharmaceutical industry conferences.

Dr. Vincent has over thirty-four (34) years of experience in the healthcare industry specializing in the Biotechnology and pharmaceutical industries. He has over (29) twenty-nine years dedicated to the field of Commissioning, Qualification, and Validation (CQV) He has B.Sc. degrees in industrial microbiology, as well as a Master of Public Health and Ph.D.

He has hands-on experience in many areas of Regulatory Affairs, Quality Assurance,

Commissioning/Qualification, and Engineering including regulatory submission preparation, Cleanroom Design Review, Microbiology Laboratory setup and qualification. He is solid in the areas of Upstream and Downstream Process Development and Validation as well as developing and implementing Cleaning Development and Validation, Aseptic Process, and Environmental Monitoring Programs. Most of his career has been in the biological vaccine industries but he has also supported the Medical Device, Biopharmaceutical, Pharmaceutical, Nutraceutical, and Biological industries.

Dr Vincent is an ASTM committee member for Manufacture of Pharmaceutical and Biopharmaceutical Products - E55 (20-07), Microbial/Sterility Assurance for Pharmaceutical and Biopharmaceutical Products - E55.06 (20-01), WK74412 - New Standard Critical Airflow Visualization and WK69826 - Standard Template for Environmental Monitoring Trend Analysis, Best Practices for Microbial Control of ATMP, and Cleaning Quality by Design, and Risk-Based Cleaning.  He also co-authored the ISPE GUIDE: Cleaning Validation Lifecycle – Applications, Methods & Controls.

He taught at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.

Inducted into Delta Omega Honorary Society in Public Health was founded in 1924 at Johns Hopkins University within the School of Hygiene and Public Health to promote the graduate study of public health, and to recognize outstanding achievement in the new field

Andreas Schreiner graduated from the University Erlangen, Germany in 1996 in Chemical Engineering. After a Ph.D. and a scholarship at the University College London he joined Roche as Head of Solids Processing. He moved in 2006 to Novartis and worked in various departments with increasing responsibilities from project leader to global technology platform leader.

Since 2013 he is Head of Validation for Solid Dosage Forms, leads the Global Validation Network and was involved in many health authority inspections.

Andreas is President of the Swiss Society for Process Engineers.

Liz Dallison has over 20 years experience in Cleaning Validation for the Pharmaceutical industry. She holds a BSc in Analytical Sciences from the University of Greenwich. Her expertise in cleaning validation was gained at Pfizers investigational medicinal products facility at Sandwich. Liz has a breadth of knowledge on the subject, including equipment grouping strategy, limit setting, sampling, analytical method validation, risk assessments and documentation of cleaning studies.

Liz has led a team providing validated methods for residue testing following both solid and liquid dosage product manufacturing. She is also experienced in training colleagues in all aspects of the cleaning validation program.

Liz has spoken at previous conferences and was one of the contributors to the ISPE Cleaning Validation Lifecycle – Application, Methods and Controls guidance.

After over 30 years service, Liz retired from Pfizer in 2024.

James is based in the UK with a global support role at F Ziel (Germany) who manufacture technologies for environmental control in sterile pharmaceuticals & ATMP manufacturing. Together with the role at F Ziel James is Ex-Chairman and an honorary member of the Not-for-Profit PHSS: Pharmaceutical & Healthcare Sciences Society. Working experience includes 10 years in radio pharmaceutical manufacturing and over 30 years working in sterile medicinal product manufacturing support where increasingly aseptic processing applies to ATMPs, particularly Gene and Cell therapies. James is a Subject matter expert in Barrier Technology (Isolators and RABS) and Bio-decontamination with Hydrogen peroxide vapour (H202-VHP). James is also a Member of ISPE and PDA UK Chapter Board member.