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Public Health Care (Open to ALL)

Expanding Access to Public Health Education: MoHFW Courses Open to All Health Professionals and General Public

Public Health Trainings (Authorized Health Professionals)

These online Public Health Training modules are designed specifically to train healthcare workers employed across different organizations within MoHFW.

CDSCO

Risk Based Inspections of Drugs Manufacturing Facilities from 08 to 12 May 2023

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Risk Based Inspections of Drugs Manufacturing Facilities from 08 to 12 May 2023

About the Course

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Risk Based Inspections of Drugs Manufacturing Facilities from 08 to 12 May 2023

Background, Schedule M

Quality Risk Management ICH Q9 and PQS- ICH Q10

Pharmaceutical water system and its qualification

Qualification of HVAC System, Area Qualification of Sterile and Non sterile area

Stability Study of Pharmaceutical Products

Media Fill Simulation Studies

Data integrity

Soft skills

Non compliances obsereved during Not sterile dosage form facility inspections

Concepts of OOS, Change Control, Deviation and Trend Analysis

GCP Inspectoin Inspection Techniques

Planning, Conducting inspections based on RB approach & Writing effective inspections repo

Recent advances and trends in the analytical instrumentation techniques and its applicati

An overview of GLP Schedule L-1 and Analytical method Validation in Pharmaceuticals

Process Validation

Control on Raw Materials , packaging materials and Vendor Qualitfication

Non Compliances observed during Sterile dosage Form facilities

Cleaning Validation
Certificate

Certificate