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.