FDA Regulatory Affairs Professional Expert Witness

Experience

March 1994 to Present
President & Senior Consultant, Self-Owned FDA Consulting Firm in Pennsylvania

Advise drug, device, cosmetic and food establishment on FDA regulatory affairs & compliance issues;

Formulate Standard Operating Procedure (SOP) systems for drug, device, cosmetic and food firms;

Create regulatory FDA & EU submission packages for both drugs & devices;

Conducted cGMP compliance audits under HACCP, QSR, QSIT & drug cGMPs;

cGMP & ISO training for both management and operating personnel;

Wrote validation protocols for processing and analytical methods for both drugs & devices;

Wrote IQ’s/OQ’s/PQ’s for facility, processing & analytical equipment for both drugs & devices;

Services rendered to: Bristol-Myers Squibb Company; Watson Pharmaceuticals, Inc.; Ferring Pharmaceuticals, Inc.; Schering-Plough Corporation; Becton Dickinson, Transdermal Systems Division; BioPharm Pharmaceutics Services, Division of IBAH, Inc.; BioPharm Clinical Services, Division of IBAH, Inc.; CellPathway, Inc.; TriPoint Medical, L.P.; OHM Pharmaceuticals, Inc.; Accra Pac Group; Particle Size Technology, Inc.; PathoGenesis, Inc.; Therakos, a J & J Company; Chirex; Glenmark Therapeutics, Inc., USA; Medcomp; Marteck; Medeikon; Becton, Dickinson & Company; Collogan; General Devices; Mack Molding; Moss Hospital Driver Training Rehab Center; Nano Ink; OR Specific; Haywood Vocational Services; Polk Vocational Services; International Sterilizers, Inc.

August 2003 to June 2007
Director Regulatory Affairs & Compliance, Medeikon Corporation in New Jersey

At this Medical Devices Design and Development Firm Expert 272 was responsible for:

FDA & EU regulatory affairs & compliance issues, including negotiating with FDA Headquarters review teams and EU Notified Bodies (e.g. MHRA);

Interacting with FDA Newark District staff;

Formulating Standard Operating Procedure (SOP) systems that are in complaince with both FDA QSR and ISO-13485 requirements;

Creating regulatory FDA & EU submission dossiers;

Conducting GMP compliance audits under FDA’s QSR/QSIT, and ISO-13485 requirements both internally and externally;

QSR & ISO training for both management and operating personnel;
Coordinating design development documentation generation, such as, but not limited to, generation and control of verification and validation procedures & protocols, confirmation that design outputs fulfill design input requirements, and monitoring and control of pre-clinical animal studies and human clinical trials;

Responsible for overseeing IQ’s, OQ’s, PQ’s for facility, processing & analytical equipment;

July 1990 to March 1994
Manager Regulatory Compliance, Affairs, Quality Assurance, Quality Control, Materials Management
Johnson Matthey, Inc., Biomedical Materials – New Jersey

Supervised a staff of six analytical chemists, a laboratory supervisor, a quality assurance auditor, and a materials management coordinator.

Managed an over a half a million dollar annual budget at this manufacturer of bulk drug substances;

Conducted extensive training courses in FDA bulk drug substance cGMPs and GLPs, and within six months of its inspection, created a ISO certified control system within this bulk manufacturing facility;

Responsible for regulatory compliance & affairs, quality control laboratory, quality assurance, materials management;

February 1990 to July 1990
Principal, Regulatory Compliance Consulting Services Company in Pennsylvania

See FDA Regulatory Consulting, Inc. above

September 1989 to February 1990
Director, Quality Assurance, Able Laboratories, Inc., New Jersey

Supervised Quality Assurance personnel
Created & reviewed data in Abbreviated New Drug Applications
Responsible for assuring adequate regulatory compliance
Performed extensive cGMP training

March 1987 to August 1989
Manager, Regulatory Audits, Lemmon Company, Pennsylvania

Managed a staff of five people, Validation Coordinator, Validation & Calibration Technician and the Specification Specialist;

Conducted extensive training courses in FDA sterile and non-sterile dosage cGMPs

September 1976 to March 1987
Investigator, Food and Drug Administration, Montgomeryville Resident Post, Montgomeryville, PA

Performed comprehensive GMP inspections of, drug, device, cosmetic and food establishments;

Conducted complaint investigations, including the initial follow-up investigation to the first “Tylenol” cyanide poisonings;

Received two citations for work accomplishments;
Selected under FDA’s “Long Term Training” program to attend Temple University School of Pharmacy’s graduate program in “Pharmaceutical Quality Assurance Control”;

Responsible for coordinating the “Medicated Animal Feeds” program for the Philadelphia District of the FDA;

Selected to give training to FDA, State and foreign health officials & junior level personnel;

Made presentations before FDA and industry professional on FDA compliance topics of interest;

Regulatory Affairs Submission Experience

Available Upon Request

Professional Affiliations

Central Atlantic States Association of Food and Drug Officials; Association of Food and Drug Officials

Speaking Engagements

Barrett International, GLPs vs. CLP’s vs. GMPs”;

Beijing, China Drug Conference sponsored by the Chinese Drug Administration

IBC Asia, Inc., Osaka, Japan, Hong Kong, Singapore “FDA Foreign Inspection Program for API Manufacturers”;

Military Experience

Operating Room Technician, E-5, US Air Force, Keesler Field, Biloxi, MS

Education

The Pennsylvania State University, University Park, PA, BS, Pre-Medicine

Temple University, School of Pharmacy, Philadelphia, Pennsylvania, MS, Pharmaceutical Quality Assurance Control

Civic Activities

American Legion
Loyal Order of the Moose
Loyal Order of Eagles
Squires Golf Club

References

Will be supplied upon request.

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