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Leadership



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 Loui J. Silvestri, PhDAs President of AccuReg, Loui J. Silvestri, PhD, has over 30 years of experience in the pharmaceutical, biologics and medical device industries. His combination of scientific knowledge and regulatory affairs expertise is the guiding principle behind AccuReg’s comprehensive program of services. Dr. Silvestri directs the activities of the company’s Pharmaceutical and Biological Products Divisions, and also provides strategic, technical and compliance services to AccuReg’s Medical Device clients. Dr. Silvestri has earned industry-wide recognition for successful hands-on leadership of comprehensive quality and compliance improvement programs for companies operating under Consent Decree. With his partner, Diana L. Mandli, Dr. Silvestri is also responsible for daily business operations at AccuReg.

Dr. Silvestri earned his doctorate in immunology and cell science from the University of Florida and performed post doctoral research in immunochemistry and clinical immunology at the University of Alabama Medical School. He is a founder and past-President of the Allergen Products Manufacturers’ Association. His pharmaceutical management background includes six years at Key Pharmaceuticals and Schering-Plough, where he was a Director in the department of Allergy and Immunology, overseeing R&D, Clinical and Technical Affairs.



Diana L. Mandli, RACDiana L. Mandli, RAC, Executive Vice President, is a Regulatory Affairs Certified professional with over 18 years of experience in Regulatory Affairs, QA/QC, validations, auditing, technical writing, and project management. Ms. Mandli directs the activities of the company’s Software and Computer Systems Quality/Validation Division, and also provides regulatory and compliance services to AccuReg’s Medical Device clients. Her teams are responsible for hands-on development of regulatory submissions, software/computer validation programs, Part 11 compliance evaluations and action plans, design control and documentation systems, and Quality System processes and procedures. Ms. Mandli specializes in the development and review of compliance and technical documentation (i.e., SOPs, policies, manuals, technical reports, etc.) and product approval submissions for medical devices [Dossiers, Technical Files, 510(k)s and PMAs]. With her partner, Dr. Loui Silvestri, Ms. Mandli is also responsible for daily business operations at AccuReg, and she manages the company’s Web site and marketing programs.
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