Manufacturing Site Registration

person icon Zahra Hassan Sobhy

Manufacturing Site Registration

Register any site with any health authority

updated on icon Updated on Sep, 2023

language icon Language - English

person icon Zahra Hassan Sobhy

architecture icon Business,Industry,Pharmacy,Manufacturing


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Course Description

This course is the backbone for any product registration, either pharmaceutical or medical device product with any health authority ever in the country, to register any healthcare product, the manufacturing site of this product must be registered as well with the relevant targeted health authority,  the dossiers of both the site and the product go parallel to each other as one submission to the required health authority in the targeted country for the registration.

This course is the core and the base for the regulatory affairs professionals in all countries.

In this course, we will explore together, what is the site? what are the probabilities of a site? , what are the different most common business models? and how the site is related to both manufacturer and MAH document-wise?How to prepare the dossier for the site submission? What is the SMF? and how to prepare it.

The SMF, which is the core document in the site dossier submission, we will study it in detail along with its annexes, each annex is concerning which section of the SMF.

Annex I Decrees Authorization

Annex II List of Medicinal Products and APIs

Annex III GMP Certificates

Annex IV List of Subcontractors

Annex V  Organization Chart, Duties, CVs

Annex VI Layout

Annex VII Schematic Drownings

Annex  VIII Equipment's list, FP, API, CQ

Then we will sum up our course with the registration Checklists, site layouts, and forms of different countries

and finally the SMP and its validation

Then we will handle the topic of the Site Audit at a glance, along with its probabilities, either complied or if the Audit resulted in findings so in this case, we have to raise and run CAPA

So we will close our course with the CAPA "rais, run, and close CAPA".

This unique course comes to you from the Pharma Academy from practice.

This course topic has always been on the table during interviews.

Let us build up our backbone in the regulatory affairs profession, let us build up our core dossier     

Who this course is for:

  • All Pharma industry professionals, regulatory affairs professionals, and those who deiced to start their career in the pharma industry
  • School of pharmacy fresh graduates
  • Pharma industry professionals want to boost their career
  • Regulatory affairs professional want to gain more experience


What will you learn in this course:

  • By the end of this course you will learn how to register any manufacturing site with any healthcare authority

  • Pharmaceutical Manufacturing site registration

  • Medical Device site registration

  • Register any site with any health authority

  • Register any site in any country

  • Universal site registration in any country


What are the prerequisites for this course?

  • Just laptop and willing for improvement

Manufacturing Site Registration


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

Manufacturing Site Registration
7 Lectures
  • play icon Introduction 13:33 13:33
  • play icon Site Registration Letters 14:54 14:54
  • play icon Site Submission Dossier 14:33 14:33
  • play icon Site Submission Checklist 11:47 11:47
  • play icon Site Application Forms 43:47 43:47
  • play icon SMP Validation 18:25 18:25
  • play icon Site Audit/CAPA/ Renewal 08:36 08:36

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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