ROBERT N. BORGHESE
Borghese & Associates, Inc.
20 Plantation Road
Whitehouse Station , NJ 08889
Phone: (908) 534-5354
e-mail: robert@consultborghese.com

Overview

Accomplished Director, QA/QC and Regulatory Affairs with hands-on experience with every type of FDA regulated product including pharmaceuticals, biologics, medical devices (including dental) and in-vitro diagnostic products (IVDPs). Experience includes polymerase chain reaction (PCR), home use, combination products, controlled substances, and biotechnology. Excellent rapport with FDA's CDRH, CDER, and CBER. Six (6) plant start-ups.

Certifications

Certified ISO 9000 Lead Assessor, British Standards Institution (BSI)
Certified GMP Auditor, Stat-A-Matrix Institute

Skills/Achievements

Regulatory Affairs

  • Knowledgeable of US FDA, USDA and DEA regulations
  • Successful submission of Drug Master Files, 510(k)s, PMAs, IDEs, NDAs, INDs and BLAs
  • Special expertise in cGMPs, ISO 9000, ISO 13485, European Medical Device Directive (MDD), CE, UL and CSA Mark ings
  • Environmental/Safety Officer
  • Controlled Substance Security
  • Outstanding regulatory compliance record, numerous FDA audits with no deficiencies

Quality Assurance

  • Established computerized quality systems in compliance with 21 CFR, Part 11.
  • Total Quality, FMEA, validations, complaint handling, corrective/preventive action (CAPA), documentation, environmental control, auditing, change control, statistics, and new product transfer
  • Established QA programs in US, Europe , Japan & Puerto Rico
  • Experienced trainer and communicator

Quality Control

  • Manages quality control testing activities including physical/chemical, microbiological and cell culture
  • Investigation of Out-of-Specification (OOS) results
  • Validation of Test Methods

Manufacturing Processes/Support

  • Key player in start-up of biotechnology firms
  • Purified water and water for injection (WFI) systems
  • Sterilization methods: gamma, filtration, steam under pressure, dry heat, chemical, UV Lyophilization
  • Recommended and implemented several innovative, significant cost savings programs which reduced rejects, sample costs, product quarantine time, and headcount, while increasing efficiency

Expert Witness

  • Expert in the practical implementation of FDA regulations, Adverse Drug Experience (ADE) Reporting, Medical Device Reporting (MDR), and labeling.

Work Experience/Clients

  • Acteon, Inc.
  • Allergan
  • Alpharma USHP
  • Bayer
  • Becton Dickinson
  • Calypte Biomedical Corp.
  • Corning
  • Cytogen Corp.
  • Datascope Corp.
  • Gen-Probe
  • Genisphere
  • Glenwood-Palisades
  • Hazleton Laboratories
  • International Technidyne Corp. (ITC)
  • JRH Biosciences
  • Novartis
  • Organon Pharmaceuticals USA
  • Polyprobe
  • Porton Products, LTD
  • Satelec
  • Zila Pharmaceuticals

Education

Loyola College , Baltimore , MD , Executive MBA (30 credits)
University of Virginia , Charlottesville , VA , B.A., Life Sciences
Baltimore Polytechnic Institute, Balto. , Maryland , Diploma

Professional Development

  • Published in "The Journal of the American College of Toxicology" (1990) and "BioPharm" (1990 and 1993), and “Regulatory Affairs Focus” (May, 2004)
  • Speaker at seminars and professional meetings
Member of Board of Directors, Association of Medical Diagnostics Manufacturers (AMDM)