JJ Capone
Senior Technical Advisor
- Washington, DC
- jcapone@ofwlaw.com
Providing support in the areas of medical devices, Pharma and biopharma – QSR and pre-clinical studies.
Areas of Expertise
- Quality systems for medical devices
- Quality systems assessment and audit
- Response to FDA regulatory actions
- Development of corrective action plans
- Process validation
- Process control
- Design validation
- Sterile and non-sterile devices
- Reprocessed devices
Practice Areas
- Medical Devices & Products
- Pharmaceuticals & Biologics
- Hospitals & Health Systems
- Coverage & Reimbursement
- Digital Health
- New & Advanced Payment Models
- Advocacy & Public Policy
- Executive & Regulatory Advocacy
- Inspections
- Litigation
- Consumer Product Safety Law
- Occupational health & Safety Law
- Supply Chain Distribution
- https://ofwlaw.com/tag/cosmetics/
Credentials
Education
BA New York University,
MS Florida State University,
PhD Florida State University,
Post-Doctoral U of Illinos Medical
News & Insights
Extensive publication in areas of compliance, regulatory responses and approvals
Leadership & Community
- Sigma Xi - Honorary Research Society
- Amer Assoc for Adv of Science
- Regulatory Affairs Society - emeritus
