23021_Quality Assurance and Quality Control

Program Overview:

The Certificate Program in Quality Assurance and Quality Control is a comprehensive and online training program that focuses on the principles, methodologies, and best practices of QA and QC. Participants will gain a deep understanding of quality management systems, processes, and techniques to ensure products and services meet or exceed customer expectations.

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: 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 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.