PROFESSIONAL EXPERIENCE • Published author of pharmaceutical, device and biologics compliance textbook
• Presenter at major pharmaceutical and biotechnology conferences worldwide
• International Quality Assurance and Regulatory Strategizing Specialist
• Specialization in pharmaceutical, medical device and biologics manufacturing and controls for FDA Inspection-readiness
• Independent consultant to private and government FDA-regulated organizations
Precision Consultants, Inc. President and Founder, Coronado, California
International Consultant to FDA regulated industries with a special emphasis on: pre-approval inspections; quality assurance audits; Regulatory Strategizing: CMC, NDA, and PLA/ELA reviews; due-diligence audits; consent decree compliance upgrades; start-up facility validation master plan. To date, have inspected over 1000 different medical device, pharmaceutical and biologic manufacturing firms throughout the U.S. and abroad.
University of California in San Diego Professor of “Advanced Quality Assurance for Biotechnology”
Ivax Corporation Director, Regulatory Affairs and Product Development
Responsible for all phases of product development for veterinary subsidiary-DVM Pharmaceuticals, Inc. Handled product conception, design, and researched product viability, including, scale-up, cost-analysis and regulatory submissions. Interfaced with Medical Director, manufacturing, marketing and sales. Developed and placed into commerce four new products. Established and implemented a QA and QC program; created SOPs; prepared all regulatory submissions, including ANADAs and NADAs. Coordinated with market research to define new products and product positioning. Responsible for all product labeling and insuring compliance with EPA, FDA and state regulations.
United States Food & Drug Administration Lt. (03), United States Public Health Service - Field Investigator - Miami, Florida Independently carried out assignments that covered the full range of industries under FDA’s jurisdiction; conducted undercover investigations and complex inspections of drug, medical device, food and cosmetic manufacturing companies; insured conformance with FDA regulations and good manufacturing practices; prepared concise, factual reports of investigative findings; provided basic training to lower grade inspectors and support personnel; testified in court on matters related to adverse investigational findings; participated in joint investigations with other law enforcement and accreditation agencies; in addition, was prepared to serve the USPHS as an active duty, Commissioned Officer in times of war or national emergencies. Served under Surgeon General’s Dr. E. Koop and Dr. A. Novello.
Awards and Honors • National Retention Fellowship Program: Columbia University’s School of Administrative Medicine, 1979
• Harvard Medical School’s Summer Preparatory Program, 1978-81 Scholarship
• Commissioner’s Special Service Citation, 1990 (Dr. E. Koop)
Education • Master’s Degree in Public Health, Columbia University School of Public Health, New York, 1987
• Columbia University School of Physicians & Surgeons, 1988
• Bachelor of Science, City College of New York, Cum Laude, 1978
• Doctoral Studies: Medical Anthropology
Personal Data
• Multi-lingual: English, Spanish, French, Portuguese
• Triathlon, endurance sports
Publications Latest publication: “The Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics” (745 pgs., Marcel Dekker, publisher)
• “Forward-Thinking Quality Systems for the Millennium, Journal of GXP Compliance,” January 2003, Vol. 7, No. 2
• “Preventing Regulatory Crisis in an FDA-Regulated Environment: A Three-Part Series” May 24 2001; Journal of GXP Compliance
• “In-House Development and Validation of Analytical Methods Standards for Biologics:Technical and Regulatory Concerns,” BioPharm, August 1997, Vol. 10, No. 8
• “CGMPs Quiz,” Pharmaceutical & Cosmetic Quality, August 1997
• “The Psychology of Validation,” Journal of Validation Technologies, November 1995, Vol. 2, No. 1
Presentations Course Developer and Director • Quality Assurance During all Phases of Clinical Trial Activities: GCP Risk Management
• The Drug Development Process and Your Business Plan
• Unprecedented and Unique Compliance Challenges in the Biologics Arena
• Inspection-readiness Strategies for Team Biologics
• Regulatory Compliance: The FDA Inspection - How to Successfully Prepare For, Manage and Respond to an FDA Inspection
• How to Effectively Prepare for an FDA Pre-Approval Inspection
• Compliance and Regulatory GCP Readiness Training: A Team Approach
• The New Medical Device GMPs: A Quality Systems Tool Kit
• Predicting, Preempting and Managing Crisis in an FDA Regulated Environment
