J.J. Capone

Phone: (202) 789-1212
Fax: (202) 234-3550

J.J. Capone, MS, PhD, is a Senior Technical Advisor at OFW Law. Dr. Capone advises companies on compliance with Food and Drug Administration (FDA) regulations, with focus on matters related to quality and regulatory aspects related to medical devices and pharmaceuticals. This includes:

  • Assistance in the preparation of Premarket Approval Applications (PMAs), Premarket Notifications (510(k)s
  • Advice, training, and assistance with matters concerning the Quality System Regulation (QSR)
  • Assistance with responding to and resolving issues relating to:
    • Technical, engineering and scientific aspects of product development and maintenance
    • Quality System assessments and development of Quality System Improvement Programs
    • Responses and project management of 483, Warning Letter and Consent Decree actions
    • Recalls;
  • Development of design and process validations
  • Training related to:
    • Investigations
    • CAPA
    • Test method validation
    • Process validations

Dr. Capone received his BA in Biological Sciences from New York University, and his MS and PhD in Microbiology from Florida State University. He was involved in post-doctoral studies at the University of Illinois in immunology. He has been involved in clinical laboratory research in the development of in vitro diagnostics, artificial organ development, and medical instrumentation. He has been an independent consultant since 1987.

Practice Areas

  • Medical Devices (disposable, capital, sterile, non-sterile)
  • Drugs (process controls and method validations)
  • Biopharmaceuticals (process controls and method validations)

Education

  • University of Illinois (Chicago) Post-Doctoral Studies
  • Florida State University PhD
  • Florida State University MS
  • New York University BA

Professional Associations and Memberships/Clubs

  • Research Society of Sigma Chi
  • Regulatory Affairs Professional Society (RAC) – emeritus
  • American Society of Quality – emeritus
  • American Society of Clinical Pathology – emeritus
  • American Society of Microbiology - emeritus