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Expert Profile

Zintro ID: Mike-*****
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25yrs experience in CMC/510K development and licensing of Biotech, Pharma, Medical Device at the most successful companies.

 
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Chemistry, Manufacturing, And Control (CMC)
Validation
Assays
CMC Sections Of Regulatory Filings (MAA, NDA, BLA)
Design Validation
Project/Program Magement
Fermentation
Protein Purification
Sterilization, Decontamination, Aseptic Packaging
Quality Assurance
Risk Management
Specifications And Plans Review
Virus Production
Antibody Production
Technology Transfer: Process And Assay
Combination Products
Medical Device Design Control
Quality Systems Design & Implementation
Quality Assurance And Management
Software Validation
Facility Management (biotech And Pharma)
Preparation Of CMC Documentation DS And DP
Sterilization
Sterilizer Validation - EN17665, EN285, HTM2010
Drug Manufacturers, Sterile And Cytotox
Sterile Filtration
Environmental Monitoring For Aseptic Process
Aseptic Processing
Qualification Of CGMP Facility
Analytical Method Development And Qualification
Controls/Automation Qualification
Site Assessment And Project Qualification
Supplier Qualification
Process Engineering And Project Management
Bio Process Engineering, Pharma Market
Process Change And/or Improvement
Change Control Systems
Manufacturing Process Validation
Biologic Facility Design, Start-up And Validation
Biotech Startup
GMP Manfacture Of Biologics And Parenterals
Global Quality Assurance (GCP, GMP)
Indepth Knowledge About GMP Requirements
Validation Of GMP/GLP Facility
Regulatory Compliance (GMP, GLP, GCP)
Quality Assurance (ISO, GMP, HACCP)
Management Of Development Teams For Biologics
Outsourced Drug Substance Manufacture
API And Drug Substance Manufacturing
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