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 As President of AccuReg,
Loui J. Silvestri,
PhD, has over 25 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, RAC, Executive
Vice President, is a Regulatory Affairs Certified
professional with over 13 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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