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Marsha Steed
Steed MicroBio LLC
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Services
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Development of a CCS
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Development of an EM Program
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Facilitation of an EM Risk Assessment
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Facilitation of an Aseptic Process RA
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Facilitation of Microbial Process RA
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Development of Cleaning Program
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Development of DE Studies
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Investigation of Media Fill Failures
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Contamination Investigations
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Sampling Plan Development
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RMM Evaluation
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US and EU cGMP Compliance
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503b and Compounding Pharmacy
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Sterility Assurance
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Aseptic Processing Expertise
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ATMP Expertise
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Facility Design Review
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Audits and Mock Inspections
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Expert Witness
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Pharmacopoeia Compliance
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Sterility Testing Isolator Design
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Isolator Design & Validation
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