Consultants and Trainers

Founder

Jorge A. Castaños

Jorge has extensive QARA experience gained from deep involvement in all aspects of development, and manufacturing of medical devices and drugs. He has broad experience in quality systems, operations, and regulatory compliance, coupled with a strong work ethic and diligence. Jorge's background includes work with global systems across international locations for major corporations. 

Education

TEMPLE UNIVERSITY SCHOOL OF PHARMACY
M.S., Pharmaceutical RA/QA

J.L. KELLOGG SCHOOL OF MANAGEMENT,  NORTHWESTERN UNIVERSITY
MBA

KNOX COLLEGE
B.A., Chemistry

Experience

• 15+ years in Medical Device & IVD, and 20+ years in Pharmaceuticals

• Plant Operations / Quality Ops

• Multi-site / International Quality Systems management

• Global Regulatory / Compliance

Responsibilities/Positions

• Founder, Quality & Regulatory Compliance Corporation

• Vice President , Quality & Regulatory, Integer | Cardiac Rhythm Management & Neuromodulation

• Vice President, Quality Systems, Smiths Medical

• Center of Excellence for Drugs, Abbott Laboratories | Global Pharmaceutical Compliance

Areas of Expertise

Including, but not limited to:

Products:

• Drug solid dosage forms

• Aseptically filled pharmaceuticals

• Active pharmaceutical ingredients

• Orthopedic, surgical and implantable devices

• Electromechanical devices

• Vascular infusion pumps and drug delivery devices

• Endotracheal and airway management devices

• IVD / Immunodiagnostics

Disciplines:

• Pharmaceutical GMP, GLP

• FDA Quality System Regulations – 21 CFR Part 820

• ISO 13485 Quality Management Systems

• US FDA establishment registrations, device listings and 510(k) submissions

• CE Marking ‐ Technical Files

• US FDA Vigilance, surveillance, and Field Corrective Actions

• Risk Management ISO 14971 for Medical Devices

• Form 483 and Warning Letter remediation and Conflict resolution with FDA District Offices

Activities & Affiliations

• ISO13485:2016 Lead Auditor, British Standards Institute (BSI)
• Aseptic Drug Processing, PDA - Parenteral Drug Association