Ministry of Health and Family Welfare
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National Institute of Health and Family Welfare (NIHFW)
6th RTP on Risk Based Inspections of Drugs Manufacturing Facilities
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About the Course
Earn a career certificate
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Background, objective and expected outcomes of training, Schedule M (GMP)-Objective and Components
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Quality Risk Management ICH Q9 and PQS- ICH Q10.
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Pharmaceutical water system and its qualification
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Qualification of HVAC System, Area Qualification of Sterile and Non sterile area
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Stability Study of Pharmaceutical Products
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Media Fill Simulation Studies
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Data integrity
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Soft skills
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Non compliances obsereved during Non sterile dosage form facility inspections
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Concepts of OOS, Change Control, Deviation and Trend Analysis
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Good Clinical Practices Inspectoin: Inspection Techniques
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Planning, Conducting inspections based on Risk Based approach & Writing effective inspections reports
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Recent advances and trends in the analytical instrumentation techniques and its application
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An overview of GLP Schedule L-1 and Analytical method Validation in Pharmaceuticals
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Process Validation
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Control on Raw Materials , packaging materials and Vendor Qualitfication
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Non Compliances observed during Sterile dosage Form facilities
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Cleaning Validation
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Post Assessment
Assessment
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Certificate
CDSCO Certificate
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