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Analyst and Reviewer Qualification Procedure
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Analytical Instrument – Equipment Qualification
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Analytical Method Transfer (AMT) procedure
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Aseptic Technique for Microbiological Testing
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BMR and BPR Review Procedure
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Change Control Management
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Contract Laboratory Agreement and Testing
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Corrective and Preventive Actions (CAPA)
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Do’s and Don’ts In Microbiological Laboratory
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Electronic Signature and Audit Trail Review – Empower
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Employee Training and Development
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Entry and Exit Procedure In Microbiology Laboratory
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Good Chromatographic Practices (GCP)
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Good Documentation Practices (GDP)
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Handling of Deviation & Incident
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Handling of Extraneous Peak
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Handling of Out of Specification (OOS)
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Handling of Pharmacopoeial Changes
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Handling procedure Out of Trend (OOT) Test Results
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Internal Audit (Self-inspection) SOP & Checklists
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Introduction of New Product (Risk Assessment)
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Isolation and Identification of Microorganism
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Laboratory Standard Management (WS,WRS Qualification)
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Management of Microbial Cultures
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Master Batch Record (MBR) Management
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Microbial culture suspension preparation, cell enumeration
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Microbial Swab Recovery Validation
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Microbiological analysis of In-process samples and finished Product
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Microbiological Media Management
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Preparation of Cleaning and Sanitation Solution for Microbiology Laboratory
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Prevention of Cross Contamination, Mix-Ups and Microbial Contamination
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Quality Risk Management (QRM)
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Recovery of Label of Spore Count of Biological Indicators
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Reduce Testing Procedure for Raw Material
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Review of Analytical Raw Data & Report
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SOP design and Management (SOP on SOP)
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Stability Study of Drug Product
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Technology Transfer of Drug Product
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Washing and cleaning procedure for Glassware in Microbiology Laboratory
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