USP Chapter <797> Consultants

June 2012 - Vol.9 No. 6 - Page #20
Category: Environmental Monitoring Consulting

The following is a list of pharmacy consultants from across the United States who specialize in USP Chapter <797>-related issues.















E. Clyde Buchanan, LLC
Clyde Buchanan, MS, RPh, FASHP
1410 Brawley Cir NE
Atlanta, GA 30319770-458-0304

Clyde Buchanan, MS, RPh, FASHP, is a pharmacy consultant and expert on compounding sterile preparations and pharmacy planning, budgeting, and operations. With 28 years of experience as a hospital pharmacy director, he has the expertise to help pharmacists in meeting sterile compounding standards. E. Clyde Buchanan, LLC’s mission is to improve the safety of sterile compounding by using the best standards, the most practical procedures, and the most cost-effective equipment and supplies for any facility’s needs.

Clyde provides his assistance to help hospitals conduct gap analyses of sterile compounding operations, build strategic master facility plans, and develop functional floor plans. He works with pharmacy organizations to put together training presentations on sterile compounding, as well as pharmacy department strategic planning and budgeting. In addition, Clyde can aid hospital pharmacy requests for proposals and proposal reviews for cleanroom vendors, architects, hood and isolator vendors,training programs, environmental monitoring companies, and procedures. 















Microbiology Research Associates, Inc
Fran McAteer, MS, MBA
33 Nagog Pk
Acton, MA 01720

Microbiology Research Associates, Inc offers a full service program for USP <797> compliance. Services provided include: cleanroom design and engineering; room certification; environmental monitoring; full microbiology laboratory service for USP <71> sterility tests, USP <85> bacterial endotoxin tests, and species IDs; on-site pharmacy staff media proficiency programs; cleanroom cleaning and sanitization services; quality SOPs; automated compounding device validation; equipment calibration; USP <797> compliance audits for outsourced CSPs; robotic fill automation validation; stability testing; and personnel educational seminars.















Clinical IQ, LLC
Eric Kastango, MBA, RPh, FASHP
184 Columbia Tpke, Suite 4, 
Florham Park, NJ 07932 
Fax: 866-538-4783

Eric Kastango, MBA, RPh, FASHP, is the principal of Clinical IQ LLC, an international health care consulting firm that assists clients who require expertise in the area of sterile liquid and oral solid dosage form preparation, packaging, and distribution; USP Chapter <797> compliance; pharmacy- and pharmaceutical-based aseptic processing; medical device manufacturing; and the implementation of process control and quality management systems. Since 1980, he has practiced pharmacy in a number of practice settings, including hospitals, community, and home care.

Eric is an active member and fellow of ASHP, has served on the USP Sterile Compounding Committee from 2005-2010, and has been re-elected to the 2010-2015 USP Council of Experts, Compounding Expert Committee. Eric has authored over 150 invited national and international professional presentations on a variety of pharmacy practice topics, including sterile product preparation, pharmacy compounding errors, process improvement, and quality management systems.















Controlled Environment Consulting
James Wagner
2527 King’s Mill Rd 
Hellertown, PA 18055

Controlled Environment Consulting (CEC) provides specialized consulting services to the sterile compounding community. The company president, Jim Wagner, has been an active member of the cleanroom and containment industry since the late 1970s. That experience, in combination with his 2005-2010 appointment to the USP Sterile Compounding Committee responsible for chapter <797>, NSF/ANSI 49 Standard Steering Committee for Class II Biological Safety Cabinets, and the CETA CAG-002-2006 Isolator Applications Guide allows CEC to confidently guide you through the difficult aspects of equipment selection for both hazardous and nonhazardous compounding. 

CEC has worked with over 100 pharmacy and facility staffs to pick the best solutions and integration strategies for their sterile compounding applications, and remains committed to bringing best practice applications to sterile compounding facilities.















Performance Strategies, LLC
Kate Douglass, MS, RN, APN,C, CRNI
568 Cliff St
Ridgewood, NJ 07450

Performance Strategies, LLC works to improve patient care and ensure desired patient outcomes by assisting customers in improving their sterile drug compounding and administration practices. Performance Strategies works with a wide range of clientele, including the medical,nursing, and pharmacy communities in hospitals and alternate site settings. Performance Strategies designs approaches that help clients achieve desired work-performance through a variety of educational and operational strategies.

Kate Douglass, principal of Performance Strategies, has experience in supervising the design, engineering, and building of four pharmacy compounding complexes that meet USP <797> facility requirements. Additionally, Kate is a study co-director for the USP <797> Compliance Study, and is one of CriticalPoint’s expert authors. She has written numerous articles on sterile compounding and training. 















LDT Health Solutions, Inc
Lou Diorio, RPh, Principal
Dave Thomas, RPh, MBA, Principal
38 Cedar Pl Wayne, NJ 07470

LDT Health Solutions, Inc (LDT) is a health care consulting firm with expertise in all areas of pharmacy practice, including regional compounding management, compliance, regulatory affairs, and quality management.

Quality Management: LDT has over 20 years of expertise developing solid, easy-to-read policy and procedure manuals that can be followed by all employees to enhance the level of service provided to patients. 

Compounding Automation: LDT has unique expertise in automated compounding devices and the computer conductivity needed to maximize these devices within an organization, regardless of the geography or service model. 

Outsourcing/Contract Compounding: The provision of contracted compounding pharmacy services from off-site providers is a growing model in health care. LDT’s experience in developing, constructing, and managing successful, multistate compounding facilities under both Board of Pharmacy and cGMP regulations can help guide clients through the selection process if an organization, health system, or health network is contemplating such a shift in medication delivery model.















microbiology specialists inc
Alice Weissfeld, PhD, D(ABMM), F(AAM)
8911 Interchange Dr
Houston, Texas 77054

Dr. Alice Weissfeld is the American Society for Microbiology delegate to the United States Pharmacopeia, and has been involved with formulation of the microbiology requirements for USP <797> from the beginning. Ms. Paula Vance is a forensic microbiologist who can track organisms isolated in the pharmacy to their source (eg, the HVAC system, organisms brought in from outdoors or other areas in the hospital). 

Alice and Paula are cofounders of microbiology specialists inc (msi), an accredited clinical and environmental microbiology laboratory. msi offers a range of laboratory and consulting services. Accredited by CMS in bacteriology, mycobacteriology, mycology, parasitology, and virology, laboratory services include, but are not limited to, environmental monitoring of all ISO 5, 7, and 8 areas used for sterile compounding; sterility testing of batches, as well as randomly compounded sterile preparations; annual media fill; and gloved fingertip testing.


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