Master Pharmaceutical Quality Management System

person icon Zahra Hassan Sobhy

Master Pharmaceutical Quality Management System

Pharmaceutical quality management system, medical device quality management system, site quality management system

updated on icon Updated on Sep, 2023

language icon Language - English

person icon Zahra Hassan Sobhy

architecture icon Teaching & Academics,Science,Pharmaceuticals


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Course Description

The quality management system (QMS) is the backbone concept in the pharma industry, if you are planning to register a manufacturing site, pharmaceutical product, or medical device, so in all cases, you have to be complied with the quality management system (QMS) to ensure quality, which is the major topic of concern by all health authorities globally.

The QMS is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. The QMS will help to coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

In this course we will dive deeply together into the QMS, to understand the concept behind it, and the 3 levels of quality, the role of the management towards QMS, the QMS objectives, who are the elements of the QMS are integrated together to come up with the final QMS.

Then we will practice QMS in the pharma industry, to understand what is the meaning and application of QMS in the pharma industry, to understand that the quality is a continuous process rather than just an activity that comes after the finishing of any process in the pharma industry 

quality is involved in all stages of any product Lifecycle, conations with it and going in parallel together with it.

and then will test the behavior towards the QMS, quality standards, and pharmacopeias behind it.   

Then we will explore the ISO, its definition, history, development, its clauses over the years and what is new in these clauses, and finally, the ISO outcomes which are our main target in the pharma industry out of applying and be complied with ISO.

Then come to the GMP, the core concept and document of the quality for any kind of submissions in any country

and then expanding to the wider big scope of the GXP, ending by the documentation, which is very crucial as the pharma industry is all about documentation and keeping records.

Then we will Cloe our course by personnel training to the QMS concepts and application, and finally process validation.

Let us prepare ourselves for the interesting dive, let's go.

Who this course is for:

  • Pharma industry professionals, beginners and fresh graduated who area enthusiastic to start their career in the pharma industry
  • Pharma industry beginners
  • Pharma industry professionals
  • Fresh school of pharmacy graduates
  • Pharma regulatory affairs professionals


What will you learn in this course:

  • In this course you will master the pharma industry quality management system "QMS" which is mandatory for any kind of product submissions for registration either pharmaceutical or medical devices in all countries

  • Quality management system "QMS"

  • Pharmaceutical Quality management system "QMS"

  • Medical device Quality management system "QMS"

  • Site Quality management system "QMS"


What are the prerequisites for this course?

  • Laptop and willing to learn

Master Pharmaceutical Quality Management System


Check out the detailed breakdown of what’s inside the course

Master Pharmaceutical Quality Management System
11 Lectures
  • play icon Introduction 08:31 08:31
  • play icon QMS Objectives 10:26 10:26
  • play icon Fundamentals of GMP 08:48 08:48
  • play icon Quality Standards 28:26 28:26
  • play icon ISO 9001 11:56 11:56
  • play icon GMP 14:17 14:17
  • play icon GXP 18:09 18:09
  • play icon GDP 10:13 10:13
  • play icon GMP Training 01:33 01:33
  • play icon Process Validation 09:23 09:23
  • play icon Risks 08:31 08:31

Instructor Details

Zahra Hassan Sobhy

Zahra Hassan Sobhy

This is Zahra Hassan, I'm a pharmacist, with almost 10 years of experience in the pharma industry, my experience is extended to cover the regulatory affairs field, which deals with registration and granting health authorities approval for health products, including medicines, medical devices, over the counter products "OTC", such as food supplements, and cosmetics as well.

This is in addition to the quality compliance, control, and assurance for these health products, and also ensuring product safety through pharmacovigilance activities.

I have been practicing all these professions for 10 years covering 20 countries, across the regions of the Middle East, Africa, Levant, and Turkey.

During my career journey, I gave myself lots of credits by postgraduates studies

Msc of pharmacovigilance Bordeaux university France

MBA, Chiffley buisneiss school , Australia

Dual Diploma of regulatory affairs "pharmaceutical and medical devices" RAP society, USA.

Certified lead auditor

currently enrolled in the Ph.D. program of pharmacovigilance Bordeaux university France

Despite the fact that postgraduate studies for sure will add to the profile, but the practice is something else, in the begging of my career journey I was chasing professionals asking for private lessons after work to gain practical experience from them, and it was not for free, I used to make this deal with many professionals as I can to get as much diverse experience that I can gain, in addition, I used to follow national and international pharma industry events attending, then participating from my own pocket. This simply happens when you follow your passion.

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