©2019 AccuReg Inc.

ACCUREG INC   |   13762 W STATE RD 84   |   SUITE 616   |   DAVIE FL 33325   |   954-641-6400   |  accureg@regulatory.com

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Loui J. Silvestri, PhD

President/CEO


Loui 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.


Contact Loui at loui@regulatory.com or by calling

AccuReg at 954.641.6400.

Diana Mandli is a Regulatory Affairs Certified professional with over 20 years of experience in Regulatory Affairs, QA/QC, validations, auditing, technical writing, and project management. She 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.


Diana specializes in the development and review of compliance and technical documentation (e.g., SOPs, policies, manuals, technical reports, etc.) and product approval submissions for medical devices [e.g., Dossiers, Technical Files, 510(k)s and PMAs, etc.].
 

Contact Diana at dmandli@regulatory.com or by calling

AccuReg at 954.641.6400.

Diana L. Mandli, RAC

Executive Vice President

Dr. Loui Silvestri has over 35 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. Loui has earned industry-wide recognition for successful hands-on leadership of comprehensive quality and compliance improvement programs for companies operating under Consent Decree. His guidance is at the helm of every division of AccuReg.

Alicia A. Rice, IE, CQE, CSQE

Director, Quality Systems, Quality

and Compliance Engineering

Alicia Rice has over 30 years’ experience in manufacturing, engineering and management in the Medical Device product field, including over 20 years’ consulting experience with emphasis in Quality Systems development and implementation, software/computer systems quality and validation, and GMP/QSR/CRO auditing. She is a Certified Lead Auditor and expert in the design and implementation of CAPA
systems and execution of CAPA investigations.


At AccuReg, Alicia leads consulting teams in the execution of compliance and quality system engineering projects for client firms. Some examples include: Systems re-engineering based on S4 Process, Black Belt, and Lean principles; development of CSV methodology process and procedures; development of validation methodologies and validation programs for computer-controlled processes and devices; Lead Auditor performance of SIMFAs, GMP/QSR compliance audits, gap assessments, and failure/complaint/deviation investigations.


Contact Alicia at arice@regulatory.com or by calling

AccuReg at 954.641.6400.

Roz Farrell is a Certified Project Management Professional with almost 20 years’ experience managing enterprise-wide projects in regulatory compliance, human services, and the health insurance industries. She is expert in requirements gathering and ROI reporting, budget analysis and control, business process analysis and re-engineering, RFI/RFP management, systems development methodology design, and supply chain management. She is ODI Certified for Quality Action Teams, TQM.


At AccuReg, Roz is responsible for the coordination and management of all active client projects and prospective client communications, including coordination of
all project proposals, Statements of Work and RFP responses. She often is the first responder to any prospective client’s request for information, and is the essential go-to resource for AccuReg’s clients while projects are in progress.


Contact Roz at rfarrell@regulatory.com or by calling

AccuReg at 954.641.6400.

Roz Farrell, MA, PMP

Senior Project Manager