The following is a list of pharmacy consultants who specialize in USP Chapter <797>-related issues.
Technical Safety Services, Inc
USP <797> Compliance and Engineering Specialist
620 Hearst Ave
Berkeley, CA 94710
Technical Safety Services (TSS) is the largest cleanroom testing and certification company in North America. TSS’s USP <797> compliance and engineering specialist, Andrew King, is a CETA-registered cleanroom certification professional in sterile compounding (RCCP-SC). He leads training programs for testing and certification at sterile compounding facilities. TSS has developed a systematic approach to help hospital pharmacies achieve regulatory compliance. Following a comprehensive gap analysis, TSS provides CETA-certified technicians to conduct all necessary testing and certification. In addition, TSS offers training programs designed to provide pharmacists and support personnel with a better understanding of USP <797> and best practices for maintaining compliance.
TSS understands that delivering safe, effective medication to patients is more than just a good idea—it is an obligation. For more information about USP <797> compliance services or to find out if you qualify for a complimentary USP <797> gap analysis, contact Andrew King or your local TSS representative.
Willis Triplett, PharmD
20 Waterford Court
Zionsville, IN 46077
Willis Triplett is committed to helping sterile compounding organizations understand USP <797> and implement continuous quality improvement techniques. He collaborates with a number of industry-leading entities to assist in designing a program that will meet a pharmacy’s sterile compounding needs. Services include cleanroom planning and design, personnel training and assessment, policy and procedure development, environmental monitoring and certification strategies, and inspection readiness.
LDT Health Solutions, Inc
Lou Diorio, RPh, Principal
Dave Thomas, RPh, MBA, Principal
38 Cedar Pl
Wayne, NJ 07470
LDT Health Solutions, Inc, is a medication safety and total quality management firm specializing in controlled process and quality management strategies. With over 30 years of experience in extemporaneous pharmacy compounding, cGMP manufacturing, home-care product preparation, and hospital cleanroom applications, LDT is a leader in regulatory affairs and compliance and can assist organizations in bringing forth high-quality preparations and services. Nationally recognized as experts in compounded sterile preparations (USP General Chapter <797>), LDT lends its expertise to boards of pharmacies nationwide.
LDT specializes in the development of regional compounding strategies for hospital groups and health systems of all sizes under a Pharmacy Practice or FDA-registered model (503B), and has unique technical expertise in automated compounding devices, software, packaging, and custom compounding methodologies. Through the use of proprietary point-of-failure and r-ROI (realistic-ROI) analysis, LDT develops custom solutions for each unique practice setting and particular application, enlisting a blend of automation, software, and controlled-process thinking.
Bio-Med QC, LLC
R. Douglas Haughs, Microbiologist
7950 Southeastern Ave, Unit 39259
Indianapolis, IN 46239
Doug Haughs founded Bio-Med QC to address the need for more sensitive, effective microbiology systems for the sterility control of compounded sterile preparations (CSPs). He has over 40 years of experience in sterile diagnostics manufacturing, pharmaceutical sterility control, and cGMP procedural design. As a former state public health laboratory director with experience in epidemiological and infection control microbiology studies, Doug is uniquely trained to detect and eliminate microbial contamination in CSPs. He introduced to the USP in 2005 the necessary requirements for quantitative and volumetric environmental sampling that are now required practice. Through the application of microbiology, Bio-Med QC has initiated improvements in the accuracy and quality of results available to CSP practitioners.
12154 Darnestown Rd, Suite 360
Gaithersburg, MD 20878
CriticalPoint, LLC, provides the convenience of online training and hands-on learning with an array of training and compliance tools to assist facilities with the standards of USP <797>. CriticalPoint offers:
Microbiology Research Associates, Inc
Fran McAteer, MS, MBA
33 Nagog Park
Acton, MA 01720
Fran McAteer, MS, MBA, is vice president of Microbiology Associates, Inc (MRA), an FDA-registered consulting and testing laboratory specializing in USP <797> and 503B compliance. He has expertise in sterile compounding, cleanroom engineering, environmental monitoring, cleaning, disinfecting, and contamination control. Fran’s experience is in implementation of USP <797> quality programs for hospital pharmacies. He also has expertise in GMP sterile processing, high-risk USP <797> compounding, rapid sterility methods, BUD extension, sterilization validation, process simulation studies, cleaning verification, airflow pattern testing, anticipatory compounding, and FDA remediation reports. Fran specializes in 503B compliance assessment reports for facilities utilizing outsourced CSPs.
MRA offers a full service consulting program for USP <797> and 503B compliance. These programs include cleanroom design and engineering; ISO 14644 certification; environmental monitoring program implementation; full pharmaceutical microbiology laboratory service for USP <71> sterility tests, USP <85> bacterial endotoxin tests, and species IDs; administering pharmacy staff media proficiency programs; quality SOPs; automated compounding device validation; equipment calibration; USP <797> compliance assessment reports for high-risk CSPs; robotic fill automation validation; stability testing; depyrogenation; cleaning validations; and staff USP <797> educational seminars.
Quality Solutions, LLC
801 West Baltimore St, Suite 303
Baltimore, MD 21201
Quality Solutions, LLC, assists pharmacies with USP <797> compliance in a comprehensive, cost-effective manner. Drawing from its validation, certification, cleanroom design, and testing expertise, Quality Solutions helps clients gain and maintain a documented state of control. The Quality Solution approach to USP <797> projects focuses on the pharmacy’s quality assurance (QA) system, the documented plan that details how the pharmacy complies with USP <797>.
Clients with existing QA systems can select fromcertification/testing, training, and competency assessment services to support their compliance efforts. This allows pharmacy managers to focus on compliance management instead of execution. For those who have not developed and implemented a QA system, or would like to evaluate their facility or QA system, Quality Solutions provides a facility and quality system assessment and then makes recommendations on design and quality system improvements.
All pharmacies are unique and require customized services tailored to that facility. A customized approach, coupled with integrated testing, training, and QA services, differentiates Quality Solutions.
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