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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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