IT&E International Continues to Fortify World-Class Management Team with Appointment of Tony Steinberg as Senior Director of Equipment Validation Services
Mr. Steinberg is a very highly experienced professional within the pharmaceutical, biopharmaceutical and healthcare industries and controlled environments, executing all levels of validation on process equipment and facility protocols. He has performed all levels of validation from project management, client presentations, project controls, project budgeting, corporate structuring, corporate insurance, and corporate training. His industry experiences include writing validation master plans, validation IQ/OQ/PQ protocols, protocol final reports/summaries, and SOP preparation.
"Pharmaceutical companies are increasingly looking for ways to tighten quality controls even further in every phase of their operations, from clinical trials to production. This means that if we are to continue building a reputation as one of the premier Life Science Services Organizations serving the CRO and FDA regulatory compliance needs of the pharmaceutical and biotech industries, we need leaders like Tony that will ensure the most stringent validation and quality controls," says Peter Sollenne, Chief Executive Officer of IT&E International Group.
Mr. Steinberg joined the pharmaceutical industry in 1997 as a Validation Specialist, responsible for validation and qualification programs with leading client companies such as Eli Lilly (NYSE:LLY), Merck (NYSE:MRK), Novartis (NYSE:NVS), and Wyeth Global (NYSE:WYE). He went on to take over as Project Leader for clients such as Aventis Pasteur (NYSE:AVE) and Schering-Plough (NYSE:SGP) before becoming Equipment Leader then Senior Equipment Leader, leading validation teams for Pharmacia and Upjohn. Steinberg then took on the role of Senior Validation Consultant on projects for Dow BCMS (NYSE:DOW) and Schering-Plough, before becoming Director of Equipment & Facility Validation for clients such as Genentech (NYSE:DNA), La Jolla Pharmaceuticals (Nasdaq:LJPC), and Boston Scientific (NYSE:BSX). Most recently, Steinberg has been supporting, for nearly two years, the role as Acting Validation Manager for one of IT&E's major customers, VaxGen, Inc. (VXGN.PK), leading teams in the development, execution and review of IQ/OQ/PQ protocols for the area of Biological Manufacturing, included Purification and Fermentation process equipment, Utility Systems and Analytical Systems in support of VaxGen's contract awarded under the Project BioShield Act of 2004.
About IT&E International Group
IT&E focuses on providing leading pharmaceutical companies with project-based consulting services in the areas of FDA Regulatory Compliance, data management, biometrics and clinical validation throughout the clinical trials lifecycle. The company, with its talented team of industry veterans with many years of biopharma experience, utilizes the latest tools and procedures to help its clients move quickly and effectively through the FDA approval process. Its services range from providing patients for drug trials, skilled personnel for trials, enterprise software and training to manage data and ensure FDA compliance and validation of new pharmaceutical manufacturing facilities to biostatistics support and analysis, audits, contract research services, data entry and verification services and providing total clinical solutions that take companies completely through Phase IV clinical trials. The company's pharmaceutical, biotech, healthcare and other life science client list includes such well-known companies as Abbott Laboratories (NYSE:ABT), Amgen (Nasdaq:AMGN), Aventis Pasteur, Baxter Pharmaceutical (NYSE:BAX), Bayer (NYSE:BAY), Bristol-Myers Squibb (NYSE:BMY), Chiron (Nasdaq:CHIR), Eli Lilly, Genentech, GlaxoSmithKline (NYSE:GSK), Novartis, Pfizer (NYSE:PFE), Purdue Pharmaceuticals, Schering-Plough (NYSE:SGP), VaxGen, and Wyeth Global.
Included in this release are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations reflected in such forward-looking statements will prove to have been correct. The Company's actual results could differ materially from those anticipated in the forward-looking statements.
