LF Quality Consulting
SERVICES
Quality Assurance
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Quality System Development
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SOP/Procedure Development and Review
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Batch Record Review and Approval
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Risk Assessment and Management
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Deviation
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Change Control
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CAPA
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Quality Manual
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Vendor/Supplier Qualification
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IQ,OQ, and PQ
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Method Validation
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Process Validation
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IND/NDA/BLA CMC Review
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Quality System Evaluation & Audit
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Internal cGMP Audits
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Compliance Gap Assessments
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Pre Approval Inspection Support
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CMO / Supplier Audits
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Employee hiring and training
Quality Control
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QC lab setup in compliance with GLP regulation
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QC lab method development, SOP writing, and editing
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Data review; stability data review
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QC Lab GLP compliance audit
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Equipment Calibration qualification
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Method Transfer
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Validation of analytical test procedures
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Out of specification investigations
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Investigation of deviations
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QC employee hiring, and training
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Reference standard and critical reagents qualification
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Stability program
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Validation
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Master Validation Plan
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Method Qualification and Validation
Why work with LFQC?
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Lan came from research scientist background. She had been working as a scientist for over 10 years prior transfer to QC/QA area. Her research projects included developing monoclonal antibodies, gene therapy, vaccine development, etc. She understands the science behind your projects.
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Lan has experiences in setting up QA/QC functions from scratch for the preclinical stage biotech firms, and performing QC/QA operations for middle to large biopharmaceutical companies.