Throughout MRA’s history, we have educated and trained personnel from large pharmaceutical companies, hospitals, pharmacies, to biotech startups and cosmetic companies. MRA provides proficiency testing, didactic education, self-assessment questionnaires and attendance certificates to demonstrate employee understanding and competency while providing documentation for individual training files.
Aseptic technique discussion for contamination control, cleaning/disinfection, garbing (PPE), biological safety and cross contamination.
Cleanroom Basics Training
Includes CR design and operation, gowning, basic microbiology & principles of disinfection, environmental monitoring and aseptic technique.
Environmental Monitoring Training
Includes sample sites, risk assessment, viable/non-viable monitoring, media, GPT, equipment, calibration, volume, action/alert levels, techniques, PDA TR13, USP <1116>, EU Annex 1 and USP <797> specification.
Pharmaceutical Water Systems Training
Includes DI, RODI, WFI. Discuss water quality, system design, monitoring. USP/EPA criteria, sampling, TOC, conductivity and validation.
Training for current good manufacturing practices including standard operating procedures, good documentation practices, code of federal regulations, quality systems, personnel training and FDA oversight.
Aseptic Water Sampling Training
Includes water system design and operation, water quality, water microbiology, disinfection, sampling procedures, aseptic technique, dead-legs.
USP <797> Sterile Compounding Training
Includes USP <797> sterile compounding regulations including risk levels, PEC/SEC design, environmental monitoring, action levels, CAPA, cleaning/disinfection, BUD, sterility, endotoxin, stability, sterilization and staff proficiencies.
Cleaning and Disinfection Training
Includes disinfectant types, API, contact times, lethality, frequency, disinfectant preparation, mop strokes, coverage, direction, SOP’s training and corrosiveness.
Preservative Effectiveness Training
Includes USP <51> and CTFA procedures and categories. Discuss techniques, challenge organisms, pooling, neutralizer validation, toxicity and pass/fail criteria.
*Includes: On-site visit with 1.5 hour didactic powerpoint lecture, educational booklets, proficiency self-test and individual attendance certificate. Maximum of 25 attendees. For larger groups, multiple visits can be scheduled at a discounted rate.
Microbiology Research Associates, Inc. (MRA) offers personalized microbiology consulting, research and testing services to the pharmaceutical, cosmetic, medical device, biotechnology, and health care industries.
Microbiology Research Associates, Inc.
33 Nagog Park, Acton, MA 01720
Phone: (877) 304-3940
Fax: (978) 263-2786 email@example.com
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