E-mail: dfgrabarz@irclc.com
Donald F. Grabarz is a co-founder and Managing Director
International Regulatory Consultants, a Limited Liability Company,
established in 1989. He was the founder and President of DFG & Associates,
Inc., Salt Lake City, Utah, a consulting practice established in
1986 dedicated towards serving manufacturers of medical devices
and related projects on regulatory and quality matters.
Mr. Grabarz is a Pharmacist by profession having received his
degree from St. John's University in New York City. He has also
studied at Pace University and attended courses provided by the
Wharton School of Business. Prior to establishing DFG & Associates,
Mr. Grabarz has had over twenty plus years of industry experience with
significant management responsibilities in major corporations such
as Johnson & Johnson, Becton Dickinson, C.R. Bard and Symbion.
Having had extensive and intimate involvement in the evolution
of the Medical Device Amendments of the US Federal Food, Drug, and
Cosmetic Act as well as being active in the development of Safe
Medical Devices Act, and those implementing regulations. Mr. Grabarz
has lectured extensively throughout the U.S., Europe and Asia on a variety
of related subjects. He has conducted seminars and lectures on regulatory
and quality matters for such organizations as the Pharmaceutical Training Institute, HIMA (Advamed), RAPS, the Institute
for Applied Technology, the Center for Professional Advancement
and St. John's University. He has provided his expertise in conference
sponsored by Ernst & Young and Adams, Harkness & Hill. Mr. Grabarz
was instrumental in the development and conduct of a course on Regulation
and Marketing of Medical Devices at Fairleigh Dickinson University
in their Pharmaceutical MBA Program and is an adjunct professor
in curriculum development and teaching at Salt Lake Community College.
His extensive experience includes acting as technical advisor
to the HIMA (Advamed) produced training film, the "INSPECTION" and as editor
to their "RECALL" training program. Mr. Grabarz has also contributed
both feature and topical articles to various domestic and international
professional trade publications. His experience also has included
work on DEA, EPA, HCFA and OSHA matters.
Anne T. Carter, RAC
Associate Senior Consultant / Clinical
and Regulatory
Mid Valley Professional Plaza
7651 S. 700 West, Suite 105
Salt Lake City, Utah 84047-7158 USA
Telephone: +801 233-0086
E-mail: atcarter@irclc.com
Anne Carter has 20 plus years experience in clinical development
and regulatory affairs for products in the pharmaceutical, biotechnology,
and medical device industries. Anne received a Bachelor of Science
degree in Health Education from the University of Utah, and a Bachelor
of Science degree in Nursing from Westminster College. She is Regulatory
Affairs Certified by the Regulatory Affairs Professional Society (RAPS),
the Drug Information Association (DIA) and ETA Sigma Gamma..
Preceding her services to IRC, Ms. Carter's career experience
includes being a co-founder of G.R.S.A. of Utah, LLC, a small clinical
and regulatory CRO which serves pharmaceutical, medical device and
biotechnology companies. Prior to her consulting career Anne Carter
held significantly important positions within the healthcare industry
for such companies as UroQuest Medical Corporation, IOMED, Inc.,
Himedics, Inc., Microprobe Corporation, Research Industries Corporation
and, ICN Pharmaceuticals.
Ms. Carter is highly experienced, possessing expertise in the
preparation and submission of IND's and NDA's for pharmaceuticals
as well as IDE's, PMA's and 510(k)'s for medical devices. This experience
extends to providing professional services for preparation of standard
operating procedures for manufacturers; clinical trial monitoring;
clinical and GMP audits; international dossiers and, technical file
preparation to support ISO certification and CE Mark for products.
Her career includes the direct involved and responsibility for
approvals of a various drug device combination products, drug delivery
systems, DNA probe in vitro diagnostic kits and, various cardiovascular
and urology devices. She has successfully managed and coordinated
animal and human clinical studies for Phase I through IV as required
by the FDA new drug application process. Ms. Carter is experienced
as acting as the liaison for manufacturers with the FDA and other
government regulatory agencies.
