Loui J. Silvestri, Ph.D. is one of two original founders of AccuReg. As President and CEO, he is responsible for the firm's overall scientific, technical and compliance services, and he has worked successfully with numerous client firms to win FDA approval and maintain product compliance. Most recently, he served as the Implementation Director for 18-month Consent Decree compliance remediation project for Abbott Diagnostics Division, managing a team of over 60 consultants and hundreds of client personnel. The teamís efforts culminated in an FDA inspection in December 2003, which found the client in substantial compliance with the Quality Systems Regulation.
Dr. Silvestri's combination of scientific knowledge and regulatory affairs expertise is the guiding principle behind AccuReg's comprehensive program of services. He directs the activities of the company's Pharmaceutical, Medical Device and Biologics Divisions, and also serves as Sr. Advisor to the firm's software and computer systems validation group managed by his partner, Diana Mandli, RAC. He is an industry-recognized expert on electronic records and signatures (21 CFR Part 11), software and computer system validations, and other regulatory issues related to regulated electronic systems and data.
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, RAC Executive Vice President, is a Regulatory Affairs Certified professional with over 12 years of experience in Regulatory Affairs, QA/QC, validations, auditing, technical writing, and project management. She is responsible for project management and 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. She leads the Software and Computer Systems Validation/Part 11 Compliance team at AccuReg, and 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 [510(k)s and PMAs]. In addition, she frequently conducts Quality System, cGCP, design control, and Part 11 compliance audits.
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