| PharmEcology’s
founder, Charlotte Smith, R. Ph., M.S., HEM, and our other associates
all have extensive experience in the pharmaceutical industry, including the reverse distribution industry which deals with large quantities
of pharmaceutical waste. Having been part of the regulated community
as a large quantity hazardous waste generator, we recognize the
difficulty in applying the EPA’s Resource Conservation and
Recovery Act regulations to waste pharmaceuticals. It is our goal
to shorten the learning curve for others who want to insure compliance
for their organizations in a cost effective manner while also insuring
that hazardous pharmaceuticals do not enter water treatment plants
or landfills, thereby increasing the risk of exposure in their communities.
 Charlotte
A. Smith, R. Ph., M.S., HEM, president of PharmEcology® Associates,
LLC, has over 30 years of experience in the pharmaceutical industry.
She has studied the EPA’s Resource Conservation and Recovery Act
(RCRA) and related interpretations as they apply to waste pharmaceuticals
to assure regulatory compliance of the pharmaceutical reverse distribution
company she founded in 1991. An educator by training, Ms. Smith
has made hundreds of presentations to professional pharmacy groups
to share this hard won information. She says, “Quite often my
audiences have never heard of RCRA and its potentially serious impact
on organizations
and individuals. It is extremely important that they understand
how to comply with these regulations.”
Recognizing
the need to focus on disseminating this information and to develop
systems to implement compliant procedures within the healthcare
system, Ms. Smith founded PharmEcology® Associates, LLC in 2000.
She can be reached at 414-292-3959 or csmith@pharmecology.com
.
Our PharmEcologist Associates provide On-Site Risk Assessments for our clients, identifying how current
policies and procedures need to be modified to assure compliance with state and federal hazardous waste regulations.
They also continuously review approximately 1500 new NDCs and product formulations per month, determining hazardous
waste status and waste stream designations for inclusion in our online database, the PharmE Waste Wizard.
Mitchell S. Blackman is a veteran of 30 plus years
in various pharmacy practice settings, including retail, long term care, hospital, and consulting.
In the past, Mr. Blackman has served as Director of Quality and Regulatory Affairs for
Capital Returns, Inc., a pharmaceutical reverse distributor. He was responsible
for applying EPA, DEA, DOT, FDA, and OSHA regulations to hazardous pharmaceutical products and waste.
Mr. Blackman has completed the EPA 40 Hour Hazardous Material Incident Emergency Responder training
and regularly attends EPA, DOT, and DEA educational seminars to enhance his knowledge of the regulations.
He manages the hazardous waste designation process for the PharmE Waste Wizard.
John Brenna has 30 years experience in
complex pharmacy operations. He has served in multiple capacities at Rochester Methodist and Saint Mary’s
Hospitals at the Mayo Medical Center in Rochester, MN. As a Pharmacy Production Lab Supervisor, his
responsibilities included supervision of technician compounding activities, development of new formulations,
maintenance of facility and operations in compliance with state and federal regulations, and working
with physicians to prepare specialty compounds for unique medical treatments. Mr. Brenna also served
extensively in both centralized and de-centralized hospital pharmacy functions. Mr. Brenna holds a BA
from Winona State University and a BS from the University of Minnesota. He has had specialized training
from the American College of Apothecaries, University of Tennessee College of Pharmacy, and Associates
of Cape Cod. Mr. Brenna performs On-Site Risk Assessments for PharmEcology® Associates.
Elayne Dudley brings her sales & marketing
expertise in identifying and developing Business-to-Business (B2B) customer relationships for over 15 years
in the high tech industry to the PharmEcology® Associates team. As our Senior Business Development Consultant
on the East Coast, Ms. Dudley is responsible for creating and building relationships in the healthcare market,
both direct and partner based. She can be reached at (603) 772-6510 or
edudley@pharmecology.com
Monica R. Livingston has worked in the
pharmaceutical industry for 15 years, including nine years in senior management at Capital Returns, Inc.,
a pharmaceutical reverse distributor. She implemented waste categorization, disposal methods, and audit
procedures in accordance with all applicable regulatory agencies. Ms. Livingston has extensive background
in the development of Standard Operating Procedures, training documentation, and continuous processing
enhancements. Her primary responsibilities with PharmEcology® Associates include sales and customer service,
marketing management, and accounting functions. She can be reached at 414-292-3959 or
mlivingston@pharmecology.com
.
James R.
McCauley has pioneered information systems and helped organizations
use technology to streamline their business processes for over 30
years. Mr. McCauley co-founded Business Architects in 1993 to help
both large and small businesses dramatically improve their operations
through the creative use of information technology. Prior to founding
Business Architects, he was a Senior Partner at Computer Sciences
Corporation where he spent 15 years playing a key role in their
consulting organization. He manages the design of Pharmecology® Associates'
internal business processes, computer systems, databases, and the PharmEcology® website.
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