22416 Quality Management and Clinical Trials

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About Course

Module 1: Quality Tools and Total Quality Management (TQM)

  • Use of the quality systems approach within the pharmaceutical industry such as Total Quality Management and Process steps of Total Quality Management (TQM).
  • Drives a culture of Continuous Improvement in your organization at all Levels.
  • Focuses on the tools for identification and the analysis of problems- Qualitative and quantitative.
  • Helps to identify and prioritize problems quickly and more effectively
  • Assists with the decision making process
  • Provides a way of extracting information from data collected.

Module 2: Good Laboratory Practices (GLP) 

  • This module of GLP deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported and the practices intended to promote the quality and validity of test data.
  • It focusses on the principles of GLP which include organization and personnel responsibilities, test system facilities, equipment, reagents and materials, standard operating procedures, reporting of results and storage of records and reports.

Module 3: Clinical Trials 

  • To gain fundamental knowledge of ICH Good Clinical Practice (GCP), an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
  • To get a preliminary idea on Schedule Y which describes the details of application process for conducting clinical trials; responsibilities of the investigators in India.

Module 4: Clean Room Technology

  • This module provides the basics on the clean-room technology typically used in manufacturing or scientific research, in a controlled environment that has a low level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapours.
  • Emphasizes on all technical and operational measures avoiding the potential risk of contamination of products.


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Course Content

Module 3: Clinical Trials 

  • Schedule Y

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