UVENTIA - Key Persons

Job Titles:

• President
• President of the Center for Pharmaceutical Cleaning Innovation

Andrew Walsh is President of the Center for Pharmaceutical Cleaning Innovation (CPCI™) a not-for-profit research and educational organization and laboratory whose purpose is to support companies in the implementation of new ASTM Pharmaceutical Cleaning Standards. CPCI™ supports companies through research into new technologies (2 patents), educational offerings and internship opportunities for students.

Job Titles:

• Technical Service Manager
• Technical Service Manager / STERIS Corporation
• Technical Services Manager for STERIS Life Sciences

Brian Bosso is a Technical Services Manager for STERIS Life Sciences. He has responsibility for providing global technical support for pharmaceutical detergents and critical environment products and their application and validation. Brian has over 13 years of experience in the pharmaceutical and biopharmaceutical industries having previously worked at Sandoz, Aldevron, and as an onsite consultant on projects in North America, Europe and Asia. He has held supervisory and management positions with responsibilities in areas including developing and implementing cleaning validation process lifecycle, process design, analytical method development, GMP quality and regulatory remediation. He earned a Bachelor of Science degree in chemistry from the Colorado School of Mines.

Job Titles:

• Senior Technical Service Associate
• Senior Technical Service Associate / STERIS Corporation
• Senior Technical Services Associate for the Life Sciences Division of STERIS Corporation

Brook Meadows is a Senior Technical Services Associate for the Life Sciences Division of STERIS Corporation. She has over 20 years' experience developing, validating, and authoring analytical methods (HPLC, UHPLC, TOC, UV-VIS, SDS-PAGE) to support cleaning validations. She has generated methods for swab recovery and rinse water analysis in addition to studies on visual residue limits (VRL), rinsability studies, and substrate compatibility. Brook acts as a consultant and resource to pharmaceutical and biopharma industries around the globe. She assists with analytical method validation, troubleshooting, and data generation. Before STERIS, Brook performed quality control testing for the release of pharmaceuticals. She earned a B.S. in Chemistry with Magna Cum Laude from the University of Missouri, Springfield.

Job Titles:

• Consultant
• Professional Studies under the Direction of Professor

Jack Brown started professional studies under the direction of Professor Albert I. Meyers at Colorado State University Fort Collins, Colorado. Followed by a career at Syntex Chemicals, as a Principal Scientist; worked for Hoffmann La Roche, until 2002 and rose to the rank of Distinguished Scientist while working on multiple projects, such as Naproxen®, Saquinavir®, Tamiflu®. In 2002 moved to Boehringer Ingelheim Chemicals in Petersburg, Virginia as the Manager of Process Chemistry and stayed there until 2014. Between 2014 to 2019 worked at Boehringer Ingelheim Pharmaceuticals in Ridgefield Connecticut as a Principal Research Scientist and retired in September 2019 as a Senior Research Fellow.

Job Titles:

• Associate Director of EHS for Piramal Pharma Solutions

Jay L. Brown is the Associate Director of EHS for Piramal Pharma Solutions (PPS). He oversees the design, installation, & evaluation of HPAPI containment systems at PPS. He has 35 years of global EHS experience with 11 years handling potent compounds. He has an MS Degree in Occupational Health and is a Certified Industrial Hygienist (CIH) and Certified Pharmaceutical Industry Professional (CPIP). Jay is a global SME in the design and construction of high containment facilities producing OEB 5 drugs. He has conducted numerous surrogate particulate emission studies of pharmaceutical equipment per ISPE guidelines and has authored book chapters & peer reviewed journal articles in industrial hygiene & occupational medicine. He is an Adjunct Professor of Industrial Hygiene at Columbus State Community College.

Job Titles:

• President & Quality Consultant

Job Titles:

• Veterinarian
• Director Head of Toxicology

Sebastian Joseph is a Veterinarian and a Certified Toxicologist and currently working as Director and Head of Toxicology at PharmaLex India Private Limited. Dr. Sebastian has over 16 years of industrial experience that includes drug discovery, non-clinical development of drugs and vaccines, experimental toxicology and pharmacology, Good Laboratory Practices (GLP), computational toxicology, human health risk assessment, environmental risk assessment, and medical writing. Dr. Sebastian is currently involved in strategic development and consulting services in pharmaceutical product development with special reference to non-clinical and toxicological requirements; non-clinical evaluation strategy in support of IND and NDA; risk assessment of pharmaceutical active ingredients and excipients; impurity qualification of APIs and drug products; and environmental risk assessment of pharmaceuticals. Dr. Sebastian has extensive experience in preparation and review of HBELs and is involved in providing toxicological advise and HBEL assessment reports to wide range of pharmaceutical manufactures in major markets, including Europe, USA, and APAC. Dr.Sebastian is a Diplomat of American Board of Toxicology and a European Registered Toxicologist.

Job Titles:

• Product Specialist LC
• Product Specialist LC - MS / Agilent Technologies Deutschland GmbH

Tobias Weimer hat in Marburg an der Philipps Universität Chemie studiert. Seine Leidenschaft für die analytische Chemie und Chromatographie wurde bereits in der Oberschule geweckt und im Studium vertieft mit einer gezielten Ausrichtung auf analytische Trenntechniken. Über die Flüssigkeitschromatographie im Bereich LC Säulen führte Ihn sein Weg zu LC-Systemen.

William A. Hawkins is a Managing Toxicologist for SafeBridge Regulatory and Life Sciences Group. He has spent over 21-years working in toxicology, with experience in the pharmaceutical industry, as a consumer safety toxicologist in the fast moving consumer goods industry and as a study director at a Contract Research Organization (CRO). Additional experience in REACH, GHS and SDSs. He has practiced as an Occupational Toxicologist within the pharmaceutical industry for the last 11-years, specializing in worker safety hazard assessments and patient safety, Quality cleaning validation hazard assessments.