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Certificate Course in Pharmaceutical Quality Assurance
Rating: 3.6 out of 5(275 ratings)
1,115 students

Certificate Course in Pharmaceutical Quality Assurance

Basics of Pharmaceutical Quality Assurance
Created byAteos Foundation of Science Education and Research
Last updated 9/2021
English
English [Auto],

What you'll learn

  • To enable the learner to know and understand the basics of Pharmaceutical Industry
  • To enable the learner to know and understand the basics of Total Quality Management System
  • To enable the learner to know and understand the basics of Pharmaceutical Quality Assurance System followed in Industry
  • To enable the learner to know and understand the practice of Pharmaceutical Quality Assurance

Course content

6 sections • 14 lectures • 5h 32m total length

  • Introduction to Quality Assurance34:19

    Explore how pharmaceutical quality assurance plans, monitors, and provides evidence of identity, strength, safety, purity, and efficacy through planned, systematic activities and GMP/GLP practices to meet regulatory standards.

  • Quality Assurance and Quality Management Concepts23:27

    Explore how quality assurance and quality management concepts shape pharmaceutical quality through GMP, QC, ISO 9000, and QA systems, detailing roles across development, production, and distribution.

  • Equipment and Raw Materials40:28

    Explore how equipment and raw materials are selected, specified, maintained, and procured, with emphasis on cleaning, calibration, qualification, documentation, and quality control in pharma.

  • ICH -Quality Assurance Guidelines31:45

    Explore the International Council on Harmonization's quality, safety, and efficacy framework, its four-stage guidelines process, and how stability testing and cross-border standards ensure global pharmaceutical quality.

  • Quality Assurance at Warehousing of Raw Materials30:29

    Explore warehousing and materials management for pharmaceutical quality assurance, covering storage requirements, inventory models, temperature and humidity controls, labeling, dispatch, recalls, and EOQ and ABC analysis.

  • Analysis of Raw Materials9:59

    Analyze raw materials to ensure identity, purity, and quantity meet pharmacopoeia specifications; apply rigorous testing, instrument validation, deviation management, sampling, storage, and GMP/FDA compliance for safe pharmaceutical products.

Requirements

  • Bachelors in Pharmacy, Masters in Pharmacy (All specializations)

Description

As per WHO Pharmaceutical Quality Assurance can be described as follows:

Pharmaceutical quality assurance—Pharmaceutical quality assurance may be defined as the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient.

A quality assurance specialist ensures that the final product observes the company's quality standards. In general, these detail-oriented professionals are responsible for the development and implementation of inspection activities, the detection and resolution of problems, and the delivery of satisfactory outcomes.

GMP: It is the sum total of the organized arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice.

Quality Assurance (QA) is a systematic process that ensures product and service excellence. A robust QA team examines the requirements to design, develop, and manufacture reliable products whereby increasing client confidence, company credibility and the ability to thrive in a competitive environment.

The course has main feature sections such as:

1) QA Basics

2) Quality by design and TQMS

3) Validation , Inspection and Documentation

4) Quality Systems and Role in Audits

5) Return and Recall of Pharmaceutical Product

6) Quality Assurance system of HVAC

The topics have designed by Ateos Foundation of Science Education and Research's Top class Educators. This Certificate course shall be useful for the aspirants seeking certification required for the industry and to practice Quality Assurance in pharmaceutical industry.


Who this course is for:

  • Beginners as well as intermediate level of Pharmacy education

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