Ministry of Health and Family Welfare
National Institute of Health and Family Welfare (NIHFW)
RITP Newly Recruited Drugs Inspectors
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3 Enroled Students
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About the Course
Earn a career certificate
No Instructor(s)
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Induction Training of DIs Objective and expected outcomes
PDF
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Need of drug regulation in India
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Genesis of drug regulations
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Overview of Indian Drug Regulatory System
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Issues and challenges in Drug Regulation Structure, Function
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Introduction of Indian Pharma industry
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Definitions of Drugs, Cosmeticsm, Manufacure
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Statutory bodies
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Power and duties of licensing authority
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Offences and Penalities
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Procedure of Banning of Drugs
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NLEM in India
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Hathi_Committee_report_1975_0
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MashelkarCommitteeReport
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Overview of the CLAA scheme
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Overview of WHO-GMP Certification Scheme
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An Introduction to GCP
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An Introduction to Drugs and Magic Remedies (OA) Act
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Role of Pharmexcil, NPPA, DOP
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Overview of DPCO and Essential Commodity Act
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Overview of Narcotic Drugs and Psychotropic Substances Act
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Overview of IPC and Role of IPC
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Overview of RTI ACT
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Overview of BNSS
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CrPC + BNSS Comparison Table
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BNSS 1
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BNSS 2
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RBI benchmarks
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RBI checklist
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Overview of Clinincal Trial- Regulations, Phases of Clinical trials
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RBI of Manufacturing Premises
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Overview of Prevention of Corruption Act
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Cyber Crime Investigation
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Intelligence Gathering and Verification of Complaints and Information
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Intelligence Gathering in respect of counterfeit drug manufacturers and conducting secret
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Inspection of Drugs Sales Premises, Samples Collection, Handling and Reporting
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Investigation of spurious and Not of standard quality (NSQ) drugs, Procedure for launching prosecution
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Veterinary Drugs and Misuse of drugs in Animals
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SAE in Clinical Trial and reporting, and Causality
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CT-SAE-Death- 353-2015
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Compensation Order
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CT-SAE-Death- 88-2016
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Schedule M Objectives and components
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Marketing Authorization Process of New Drugs
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Post Marketing Surveillance and its Monitoring
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Import and Registration of Drugs and Import of Drugs Under Dual use
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Non compliances Observed During GMP Audit
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Regulation Provisions for grant of manufacturing licence
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Aseptic Processing Techniques
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Seizure and Arrest
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Qualification and Validation principal (Process Validation)
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Cleaning Validation
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Utility Systems Validation_Handouts
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Concept and Definition of OOS
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Good Laboratory Practices-Schedule L1
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PvPI, HvPI, MvPI
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Overview of BSA ACT IN RELATION WITH D AND C ACT
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Validation of Analytical Methods
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Basic Principles of Stability of Drugs
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Administrative Matter CONDUCT RULES
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CCS_Conduct_Rules_1964_Updated_27Feb15_0
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Administrative Matters Sexual Harrasments
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Neutral Drug Code, Special Code, Writtern Confirmation and Export
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BA_BE Export NOC
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GOOD DISTRIBUTION PRACTICES
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Biological Products-SII PPT
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Classification of Medical Devices
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Current Regulation on Medical Devices and IVD
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NRA Assessment of Vaccines
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Inspection-Planning, Preparation, collection of evidences and report prepartion
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Blood Centres
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General Non Compliance observed in inspections in BB
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Online portals of CDSCO-Website , Sugam, ONDLS, NSWS, eHRMS, MD Online
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Administrative Matter
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Leave Rules
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CCS CCA Rules
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Administerative Matters Medical Bills
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Administrative Matters -Leave-Rules-1972
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Functions of CDSCO Port Offices
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Stress Management
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NOTING AND DRAFTING PPT
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VIP References
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Post Assessment
Assessment
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Certificate
CDSCO Certificate
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