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Michael Miller

Ph.D., B.A. ·

lutz, Florida
Pharmaceutical Microbiology
Biotech
Gene and Cell Therapy
Medical Device
Personal Care
Microbiological Monitoring
Control and Continuous Improvement Strategies
API and Fill-Finish Manufacturing
Fermentation
Recovery and Purification
Aseptic Processing
Non-Sterile Manufacturing
Environmental Monitoring
Investigations of Laboratory and Manufacturing Microbial Excursions
Out-of-Specification Findings
Laboratory Audits
Optimization and Management
Laboratory and Facility Design and Qualification
cGMP Compliance
Pharmacopoeia Compliance
Barrier Isolator Design and Microbiological Validation
Microbiology Method and Protocol Development
Validation and Technology Transfer
Contact Lens Care Formulation Development
Manufacturing
Stability Testing and Product Release
Disinfection
Sterilization and the Use of Biological Indicators
Cleaning Validation
Process Development
Regulatory Audit Response and Management
Regulatory Dossier Development Support
Process Analytical Technology (PAT)
Rapid Microbiological Method Suppliers and Industry End-Users
Next Generation Technology Platforms
Validation and Testing Plans
Financial and Return on Investment (ROI) Strategies
Commercialization Approaches
Global Regulatory and Pharmacopoeia Compliance
Investigations
Remediation and Risk Assessments for Microorganism Recovery in Nonsterile Finished Product
Burkholderia cepacia complex (BCC) and Other Objectionable Organisms
Microbiology Technology Companies
Due Diligence
Partnership
Collaboration
Merger
Acquisition
Expert Witness for Pharmaceutical Microbiology
Ophthalmic Formulations
Contamination Control
Antimicrobial and Preservative Effectiveness
Sterilization
Pharmacopoeia Interpretation and Compliance
USP Microbiology Test Methods
Laboratory and Manufacturing GMPs
Formulation Development and Stability
Sterile and Nonsterile Manufacturing
Research and Development
Product Quality
Biochemistry
Microbiology

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