Bio-Med QC, LLC
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. In 2005, he introduced the necessary requirements for quantitative and volumetric environmental samplings to the USP, which 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.
microbiology specialists inc
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. 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. 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.
Microbiology Research Associates, Inc
Fran McAteer is president of Microbiology Research Associates, Inc (MRA), an FDA-registered consulting and testing laboratory specializing in USP <797> 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, including IV, oncology, OR, allergy, and nuclear pharmacies, as well as compounding laboratories. He also has technical expertise in GMP processing, high-risk USP <797> compounding, rapid sterility methods, BUD extension, sterilization validation process simulation, cleaning verification, airflow pattern testing, anticipatory compounding, FDA audits, and FDA remediation reports.
MRA offers a full-service consulting program for USP <797> compliance, including 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; ACD 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.
LDT Health Solutions, Inc
LDT Health Solutions, Inc, a medication safety and quality management consulting firm, provides expertise in all areas of pharmacy practice, including health system compounding centralizations USP <797> compliance, regulatory affairs, and 503B facility management. With over 40 years of experience developing policy and procedure manuals, LDT now offers traditional static manuals or Web (network-based) references that can be accessed by all employees. In addition, LDT has expertise in automated compounding devices (ACDs), automation robotics, and computer conductivity to maximize these devices within the organization, regardless of the geography, service model, or bar coding requirements.
With the advent of the Drug Quality and Security Act (DQSA), the provision of contracted pharmacy services from providers is more complex. LDT brings its experience in assisting multistate compounding facilities with facility design, program development, and formulary management under these federal regulations. LDT also can guide the selection or development process of an organization contemplating a shift in its medication delivery model.
CriticalPoint, LLC provides the convenience of online training and hands-on learning with an array of training and compliance tools to assist facilities with USP <797> and <800> standards. CriticalPoint offers:
With over 25 years of pharmacy and cleanroom experience, including USP <797> and the Drug Quality and Security Act (DQSA), CAPS Consulting’s teams of compounding experts are ready to help pharmacies reach compliance standards. Whether preparing for an expansion or recovering from an audit, CAPS Consulting can help with ReadyCheck, an onsite USP <797> compliance analysis program. Auditors will examine eight categories of practice, encompassing over 200 criteria, in a 2-day period, including: cleanroom construction and design; compounding; engineering controls and certification; dispensing; cleanroom processes; media fills and training; testing and monitoring; and quality assurance.
Controlled Environment Consulting
James T. Wagner
2527 King’s Mill Rd
Hellertown, PA 18055
James Wagner served on the USP Sterile Compounding Committee for the 2005-2010 appointment cycle and has presented at many USP forums on sterile compounding. He is currently a member of the USP Compounding with Hazardous Drugs Expert Panel and has been elected to serve on the 2015-2020 USP Compounding Expert Committee. Controlled Environment Consulting provides consultation to the compounding industry, including facility gap analyses and sterile compounding facility design consultations, and has worked with over 100 pharmacy and facility leaders to identify the best solutions and integration strategies for their sterile compounding applications.
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