Consulting
At Steed MicroBio LLC, Marsha offers expert microbiology consulting services to meet your specific compliance needs.
- Development of contamination control strategies for sterile, low bioburden and non-sterile manufacturing processes
- Development or revision of environmental monitoring programs
- Facilitation of environmental monitoring risk assessments (Environmental Monitoring Risk Assessment, EMRA)
- Facilitation of aseptic processing simulation (APS) intervention risk assessments
- Facilitation of microbial process risk assessments (Hazard Analysis and Critical Control Points, HACCP)
- Development of cleanroom cleaning and disinfection programs
- Development of disinfectant efficacy studies and risk assessments
- Investigation of media fill failures
- Investigation of facility contamination events
- Microbiology sampling plan development
- Rapid Microbial Methods evaluation and validations
- US and EU cGMP compliance
- 503b and compounding pharmacy microbiology support
- Sterility assurance
- Aseptic processing expertise
- ATMP expertise
- Facility design and materials, personnel flows
- Audits and mock inspections
- Expert Witness
- Pharmacopeia compliance and interpretation (USP, EP, JP)
- Sterility testing isolator design, validation, risk assessments
- Production isolator design, validation, risk assessments
Training
Marsha offers customized microbiology and sterility assurance training to meet your unique needs.
Webinars and training classes on aseptic behaviors, development of Contamination Control Strategies (CCS), aseptic processing, aseptic process simulations, environmental monitoring, microbial risk assessments and cleanroom design, classification and qualification are also offered.