4.67
(15 Ratings)

Quality Assurance and Quality Control

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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: Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

  • This module provides basic awareness on current good manufacturing practices (cGMP) within the pharmaceutical industry.
  • Understand the roles and responsibilities associated with GMP
  • To gain fundamental knowledge of principles  and quality management under cGMP.
  • To learn and integrate good documentation practices (GDP).
  • Be able to contribute to and maintain quality documentation

Module 3: 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 4: ISO 9000, ISO 14000,  ICH GCP and Schedule Y 

  • This module helps to create a basic understanding of a set of international standards such as:
  • ISO 9000 which is a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system
  •  ISO 14000 a set of standards  which specify requirements for establishing an environmental management policy, determining environmental impacts of products or services, planning environmental objectives, implementing programs to meet objectives, and conducting corrective action and management review.
  • 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 5: 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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What Will You Learn?

  • Understand the best practices regarding control and management of manufacturing and quality control testing.
  • Gain knowledge of quality tools and recognize the principles of quality management and main guidelines & requirements of GMP thus contributing to the organization when it comes to understanding industry standards.
  • Identify the requirements for good documentation practice and different types of documents.
  • Explain the principles of validation as an essential part of GMP.
  • Understand the need for quality systems and quality assurance activities
  • Be aware of common regulatory findings

Course Content

Module 2: Good Manufacturing Practices (GMP) and Good Documentation Practices
WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization”.The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. GMP is aimed primarily at diminishing the risk inherent in any pharmaceutical production. Such risks are essentially of two types: cross-contamination (in particular, with unexpected contaminants) and mix-ups (for example, false labeling). Module Objectives: By the end of the course, delegates shall • Have an awareness of the basic requirements of GMP • Be aware of the ten golden principles of GMP • Understand the roles and responsibilities associated with GMP • Be able to contribute to and maintain quality documentation • Understand the requirements of GMP in the QC laboratory context • Understand the need for quality systems and quality assurance activities Learning Outcomes: Delegates will be able to • Implement their role within GMP with confidence and knowledge of the principle requirements • Contribute effectively to the GMP quality system and their organisation’s compliance • Know where to seek further information within the published rules and guidance, WHO, FDA, ICH Guidance and other relevant publications, as well as via the internet

  • A Brief History of the cGMPs for Pharmaceuticals
    33:02
  • Self Study Material on Various Versions of GMP
  • Principles of Good Manufacturing Practices_Part 1
    48:01
  • Principles of Good Manufacturing Practices_ Part 2
    33:44
  • GMP_ Quality Management
    50:07
  • 01:02:59
  • Assignments _Quality Management
  • Quiz 1: cGMP & GDP
  • Study material_GMP &GDP

Module 1: Types of Quality Tools and Total Quality Management

Module 3: Good Laboratory Practices (GLP)

Module 4: ISO 9000, ISO 14000,  ICH GCP and Schedule Y 
This module helps to create a basic understanding of a set of international standards such as: ISO 9000 which is a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system  ISO 14000 a set of standards  which specify requirements for establishing an environmental management policy, determining environmental impacts of products or services, planning environmental objectives, implementing programs to meet objectives, and conducting corrective action and management review. To gain fundamental knowledge of 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 5: Cleanroom Technology

Final Test

Student Ratings & Reviews

4.7
Total 15 Ratings
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AM
2 years ago
Thank you for this course. Very informative and helpful. The classes were very interesting and systematically arranged.
AP
2 years ago
This was my first time taking a course online and it far exceeded my expectations.
AF
2 years ago
This course is very interesting and ive gained good amount of knowledge and skills. Thank you to lectures for conducting this online course and explaining the topics well
KY
2 years ago
This course is useful to me and learn new lessons
AM
2 years ago
Thank you very much for this wonderfull experience. It helps us to understand and learn about quality management. The topics were well explained by teachers. Thank you so much teachers
DR
2 years ago
great course, topics were explained well by the instructors.
JS
2 years ago
Thank you all the Professors for having such a wonderful session, and very thank ful for completeing this course, which would help us in our Professional Career. Thank you Professors, Thank you all.
LT
2 years ago
Thank you very much for this wonderfull experience. It helps us to understand and learn about quality management. The topics were well explained by teachers. Thank you so much teachers
AV
2 years ago
It was an excellent course and learning with such wonderful coordinators was even more beautiful. Looking forward for more and more courses. Thankyou
CH
2 years ago
Thank you lecturers for teaching and giving a clear cut vision about the course. I was able to understand better about the quality systems. It was a nice experience .keep doing such courses in future it will help us to learn better .
JC
2 years ago
The topics were well explained , great teaching ,overall the course was very productive .Thankyou!
AB
2 years ago
Lectures was marvellous. Organized topics and clarity in teaching give awsome experience.
RS
2 years ago
Thank you all for excellent course
JK
2 years ago
Thank you for it was an amazing courses. This course has taught me many things.
DC
2 years ago
Thank you for this course. It\'s a useful course for learning how to blend and develop learning this is a very well organized online teaching technology skill-building course.