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| Microbiology
- Laboratory Management
- Assessment of existing laboratories for technical, scientific and regulatory compliance/benchmarking
- Optimization of procedures used in the laboratory
- Re-engineering of laboratory policies, procedures and methods
- Design of laboratory facilities
- Recommendation of Methods and Equipment
- Sterility Testing
- Review of sterility testing facilities and procedures
- Qualification of test suites and isolators
- Sterility Testing Positive (Failure) Analysis
- Development of Rapid Methods for Sterility Tests
- Environmental Monitoring
- Assessment of Environmental Monitoring Programs
- Development of new environmental monitoring programs
- Review and resolution of adverse trends
- Training on Environmental Monitoring for Aseptic, Terminal Sterilization and Non-Sterile Manufacturing Processes
- Microbial Data Deviations (MDDs) and Out-of-Specification Analysis
- Since the Judge Wolin’s Decision in the Barr case, handling aberrant data has been a major concern in the laboratory. A variety of resources are available to aid in handling and dealing with data deviations, excursions and investigations.
- Develop and review programs for microbial data deviations (MDDs) and out-of-specification (OOS) results
- Develop corrective action programs and implementation plans to reduce or eliminate MDD or OOS occurrences
- Training in procedures related to data deviations
- Review of existing programs for compliance and best practices
- Cleaning and Cleaning Validation Support
- Cleaning and disinfection programs are critical to effective microbiological control in pharmaceutical facilities.
- Environmental Surveys
- Development of Cleaning Validation Programs, Protocols and Procedures
- Assessment of Cleaning Procedures and Protocols
- Media Fills / Process Simulations
- Conduct of process simulation studies require detailed and comprehensive design to meet all applicable regulatory requirements. Several different areas of expertise are available.
- Understanding, identifying, and qualifying interventions
- Developing procedures and systems to reduce the number and type of interventions performed
- Process simulation Study design
- Design, Review, Conduct, and Evaluation of Failure Analysis Studies
- Development of Media Fill procedures, policies, and standards
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