Oleg has over 25 years of experience in the Clinical Research Organization, pharmaceutical, health care provider, and defense industries, and has led GXP QA and IT quality control units for much of that time. Oleg’s education includes a MS in Telecommunications Management from the Stevens Institute of technology and a BE in Electrical Engineering from the City College of New York. Oleg currently leads an IT Quality unit in a leading CRO, being responsible for quality attributes of IT processes and systems across all GXP areas. Prior to heading the IT Quality unit, Oleg managed a GMP QA unit where he was responsible for the oversight of all FDA Consent Decree CAPA remediation activities relating to computer systems and validation. During the progress of the Consent Decree remediation, Oleg was instrumental in addressing over 200 CAPA closing every single one.
Oleg has also instructed at the Bergen Community College within the Quality Assurance Program. His personal certifications included ASQ’s Software Quality Engineering (CSQE) and ISACA’s Certification in Governance of Enterprise IT (CGEIT).
Mr. Wubbolt has provided quality assurance, compliance, and computer validation consulting services since 2001, specializing in establishing data integrity programs, performing data integrity audits, vendor audits, providing training, validation, and implementing six sigma based quality improvement processes.
Mr. Wubbolt has previously worked at Aventis Pasteur as Computer Validation Manager, working with GxP computerized systems. Prior to joining Aventis Pasteur, he worked at Johnson & Johnson’s McNeil Consumer Products Company in the National Quality Assurance Group and at Lancaster Laboratories.
He was a contributing member of the GAMP Laboratory Systems Special Interest Group, which published the guidance document on validation of laboratory systems, as well as a chapter chair for DIA “Peach” guidance on computerized systems used in clinical research.
Mr. Wubbolt is a Certified Six Sigma Black Belt, has a Masters Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering. Mr. Wubbolt was the previous President of both the New England Region Chapter Society of Quality Assurance (NERCSQA) and the Mid-Atlantic Region Society of Quality Assurance (MARSQA), and is currently the chairperson of the MARSQA computer validation committee.
James Stumpff, RPh, Principal Consultant, at PAREXEL Consulting, draws on 23 years of FDA experience to improve clients’ regulatory compliance. Mr. Stumpff assists biopharmaceutical and medical device clients with a variety of projects. Examples include mock FDA audits, regulatory correspondence, remediation projects, coaching and mentoring of subject matter experts for inspection preparation and training. Prior to joining PAREXEL, he served as Investigator, Supervisor and Acting Director of Compliance with the FDA in both the New York and Los Angeles District Offices and managed the pharmaceutical programs for the FDA Los Angeles District for over 10 years. Mr. Stumpff has published articles pertaining to drug and device quality system issues including a chapter in the Parenteral Drug Association text “Data Integrity in the Life Sciences.” Mr. Stumpff holds a B.S. in Pharmacy from The University of Missouri- Kansas City.
Cozette is the Director of Americas Field Marketing at Waters Corporation, an innovative analytical sciences company. She has over 17 years of experience in supporting customers in the pharmaceutical industry, particularly with regard to regulatory compliance in analytical testing requirements and data integrity. For the past several years, she has been focused on lifecycle management as it relates to analytical methods and laboratory data in the context of modernization and efficiency efforts.
Mr. Binion is the Manager, Global Quality at Patheon. Global Data Integrity Compliance Officer and architect of Patheon's Data Integrity Governance Program encompassing multiple sites from the program's inception including behavioral management, enterprise risk analysis, remediation strategic planning, and quality culture as it pertains to Data Integrity.
Geoffrey Grove, Ph.D. is a steering committee member of AAPS IVRDT and the Chairperson of the IVRDTG Dissolution Technology sub-team. He also currently serves on a USP expert panel and a FDA expert group both in the area of dissolution testing. He has worked in the pharmaceutical industry for the past 15 years on scientific instrument development for both discovery and post production testing.
Geoffrey's doctoral degree is in the field of biophysical chemistry and he has been employeed for the duration of his career by SOTAX corporation (formerly Zymark/Caliper).
Pharmaceutical industry expert with over 25 years in the industry including small venture capital start-up, and large pharmaceutical firms. CGMP interpretation and application expertise for biotech and traditional small molecule drugs, both parenteral and solid oral.
Barbara held leadership roles of increasing responsibility in global companies such as Amgen and Eli Lilly. At Amgen she lead the corporate GMP audit program for APIs and Quality Systems. She also developed, implemented and maintained a comprehensive GMP Regulatory Intelligence program, including surveillance, analysis and communication of new or revised legislation, regulations, guidance and GMP inspection trends for major regulatory jurisdictions. She was the founding chairperson and led the Rx-360 working group for GMP/GDP Intelligence Reporting for 5 years; led the GMP Intelligence subgroup of the Midwest Discussion Group from 2010-2014; and now co-chairs the Rx-360 Data Integrity Working Group.
Currently she provides quality consulting services to the pharmaceutical and biotech industry particularly GMP auditing =in the areas of data governance and data integrity. She also is Editor in Chief for a weekly GMP Newsletter published by FDAzilla (www.FDAzilla.com). Some recent consulting efforts in the area of data integrity including complex audits and remediation performed with Validant (www.Validant.com).
Natasha Demberg is a Pharmaceutical Executive with 20+ years expertise in the development and application of Quality Management Systems throughout product life-cycle. She is skilled in leadership and management and has lead international multi-functional groups to address challenging global regulatory compliance issues. She has both hands-on expertise and a strategic view of all aspects of the pharmaceutical manufacturing process.
Natasha is presently the Vice President of Pharmaceutical Solutions at Neopharm Labs, a full service GMP analytical testing laboratory serving the Life Science industry where she is responsible for Business Development, and Customer Experience.
She is known for her dynamic leadership style and her ability to think strategically. She brings with her the tremendous mix of both technical expertise and regulatory knowledge.
Natasha’s career has included a wide range of successful leadership positions in Quality Organisations of several large companies in the pharmaceutical field. Initially as a chemist at Plantex Teva and Abbott Laboratory and later as Senior GMP Compliance Associate at Merck Frosst Canada, responsible for Quality aspect of Clinical manufacturing, and Head of Quality at Valeant Canada and Confab Laboratory responsible of entire Quality Operations.