USP Chapter <797> Consultants


November 2013 - Vol. 10 No. 11 - Page #56

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

Performance Strategies, LLC

Kate Douglass, MS, RN, APN,C, CRNI
568 Cliff St
Ridgewood, NJ 07450
201-251-4331
kdouglass@performancestrategies.info

Performance Strategies, LLC, is a consulting company focused on best practice sterile compounding and drug administration. The company assists hospitals, alternate sites, and manufacturing and commercial health care market segments. Kate Douglass, principal of Performance Strategies, designs effective and detailed policies and procedures, training programs, quality management programs, and conducts investigations and subsequent remediation of operational compounding variances.

Kate is one of the USP <797> Study codirectors and a CriticalPoint expert author, as well as a member of CriticalPoint’s Sterile Compounding Boot Camp faculty. She has written numerous articles on sterile compounding, holds a postgraduate certificate in advanced e-learning instructional design, and is currently pursuing training that will lead to Certified Professional in Learning and Performance(CPLP) certification. Kate has supervised the design, engineering, and build of several pharmacy compounding complexes that met or exceeded USP <797> requirements and was responsible for the development of all operational P&Ps.


Pharmfusion Consulting, LLC

Angela Turner Cassano, PharmD, BCPS
2110 Galloway Ter
Midlothian, VA 23113
804-517-5876
acassano@pharmfusion.com
www.pharmfusion.com

Pharmfusion Consulting, LLC, strives to improve pharmacy operations and meet client goals through clinical expertise and attention to detail. Offering a wide range of consulting services, Pharmfusion works closely with clients to provide a customized solution that meets individual sterile compounding needs. USP <797> provides the framework to keep patients safe, and compliance takes time and resources. Whether your facility is in need of didactic or hands-on training, gap analyses, or customized policies and procedures, Pharmfusion is qualified to help.


E. Clyde Buchanan, LLC

Clyde Buchanan, MS, RPh, FASHP
1410 Brawley Cir NE
Atlanta, GA 30319
770-458-0304
clyde@eclydebuchanan.com
www.eclydebuchanan.com

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, Clyde has the expertise to help pharmacists meet sterile compounding standards. His mission is to improve the safety of sterile compounding for his clients by using the best standards, practical procedures, and cost-effective facilities, equipment, and supplies. Clyde advises hospital pharmacists on a wide range of topics, including gap analyses of sterile compounding operations, strategic facility plans, functional floor plans, developing presentations on sterile compounding, and budgeting. In addition, Clyde offers consulting for proposal creation and review and recommendations for cleanroom vendors, architects, hood and isolator vendors, training programs, environmental monitoring companies, and quality assurance programs.


Microbiology Research Associates, Inc

Fran McAteer, MS, MBA
33 Nagog Pk
Acton, MA 01720
978-263-2624
mra.ma@rcn.com

Microbiology Research Associates, Inc, offers a full-service program for USP <797> compliance, including 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.


microbiology specialists inc

  Alice Weissfeld, PhD, D(ABMM), F(AAM)
Paula Vance, RM/SM(NRM), SM(ASCP), CIE(IAQA)
8911 Interchange Dr

Houston, TX 77054

713-663-6888
Kathy@microbiologyspecialists.com

www.microbiologyspecialists.com

Alice Weissfeld, PhD, 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. Paula Vance, RM, SM, CIE, 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), a clinical and environmental microbiology laboratory. Accredited by CMS in bacteriology, mycobacteriology, mycology, parasitology, and virology, msi offers a range of laboratory and consulting services, including 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.


LDT Health Solutions, Inc

Lou Diorio, RPh, Principal
Dave Thomas, RPh, MBA, Principal
38 Cedar Pl Wayne, NJ 07470
862-221-9575
LSDiorio@LDTRx.com www.ldthealthsolutions.com

LDT Health Solutions, Inc, is a medication safety and quality management firm, specializing in controlled process and quality management strategies for the pharmacy community nationwide. LDT has over three decades of experience in extemporaneous pharmacy compounding. With expertise in regulatory affairs and compliance, LDT assists organizations in developinghigh-quality preparations and services.

LDT Health Solutions offers a compounder verification program: LDT-CV. Subscribers to LDT-CV receive annual, third-party verification that all prevailing statutes, rules, and regulations for their CSP program are being met. The program is designed to assure national and local providers that their programs are compliant with industry standards and to communicate these quality indicators to their oversight agencies, customers, and prospective customers.


Clinical IQ, LLC

Eric Kastango, MBA, RPh, FASHP
184 Columbia Tpke, Suite 4
Florham Park, NJ 07932
973-765-9393
www.clinicaliq.com

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 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, Eric has practiced pharmacy in hospital, community, and home care settings.

Eric is an active member and fellow of ASHP, previously served on the USP Sterile Compounding Committee from 2005-2010, and has been re-elected to the 2010-2015 USP 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.


Technical Safety Services, Inc

Ben Gonzales, PE, CSP, President
Martin Burke, Engineering/QA Manager
Matt Smyers, Training Manager
Andrew King, RCCP-SC, USP <797> Compliance & Engineering Specialist
620 Hearst Ave, Berkeley, CA 94710
510-845-5591
info@techsafety.com
www.techsafety.com

Technical Safety Services, Inc, provides cleanroom and containment device testing and certification, as well as validation services. Headquartered in Berkeley, California, TSS maintains regional operations throughout the United States. Founded in 1970, TSS’s reputation has been built on service and quality, with decades of experience helping the biopharma community confidently control their cleanroom and production environments.

TSS provides experience and expertise to compounding pharmacists in achieving and maintaining USP <797> compliance, working closely with compounders to develop solutions tailored to individual needs. TSS also has developed seminars and educational programs to assist pharmacists in maintaining control of their compounding environments.


Controlled Environment Consulting

James Wagner
2527 King’s Mill Rd
Hellertown, PA 18055
610-428-0317
jimwagner@cenvironment.com

Controlled Environment Consulting (CEC) provides specialized consulting services to the sterile compounding community. CEC president Jim Wagner’s experience as an active member of the cleanroom and containment industry since the late 1970s, combined with his appointments to the USP Sterile Compounding Committee responsible for Chapter <797>; the NSF/ANSI 49 Standard Steering Committee for Class II Biological Safety Cabinets; and the CETA CAG-002-2006 Isolator Applications Guide; provides CEC the expertise to guide clients in equipment selection for both hazardous and nonhazardous compounding.

CEC has worked with over 100 pharmacy and facility clients in choosing the best solutions while developing integration strategies for sterile compounding applications, and remains committed to bringing best practice applications to sterile compounding facilities.


Bio-Med QC, LLC

R. Douglas Haughs, CSP Sterility Control Consultant
6212 Stoner Dr, Suite B
Greenfield, IN 46140
317-357-5000
doug@biomedqc.com
www.biomedqc.com

Founded in 2006, Bio-Med QC, LLC, provides compounding sterility control through the advanced application of preventive microbiology, specifically designed for contamination prevention in pharmaceutical and sterile diagnostics manufacturing. Founder Doug Haughs has 40 years of experience in contamination control and asepsis. He also has extensive experience creating cleanroom environments and dedicated sterility control methods and procedures for pharmaceutical and sterile diagnostic manufacturers. In 2006, Doug introduced the quantitative viable air sampling methods that are included in USP <797>.

Bio-Med QC has developed microbiology systems for compounding pharmacy quality assurance programs; these microbiology systems have been shown to increase the test sensitivity of the suggested USP media-fill test procedure through the application of appropriate microbiology and experimental design.


Quality Solutions, LLC

Jeff Lange
801 West Baltimore St, Suite 303
Baltimore, MD 21201
410-852-5267
jlange@qualsolve.net
www.qualsolve.net

Quality Solutions LLC, assists pharmacies with USP <797> compliance in a comprehensive and cost-effective manner. Drawing from its background of compliance, certification, and technical services in the biotech/pharmaceutical industry, Quality Solutions can assist pharmacy in performing a thorough gap analysis to audit a facility, its equipment, and its quality assurance program to develop and implement policies and procedures that meet USP <797> requirements.

Once a quality assurance program and action plan are in place, Quality Solutions offers a menu of technical services to maintain compliance, including coordination of design or site modifications (if necessary); implementation of revised procedures; and certification of laminar flow hoods and biological safety cabinets by CETA-certified engineers (including routine testing of HEPA filters, air changes, and pressure). Routine environmental monitoring and sampling also are available, including temperature and humidity control testing; viable (surface and air) and non-viable particulate testing; differential pressure verification; and quality assurance documentation.

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