Master Manufacturing Site Registration

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About Course

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.

The main modules in this course:

  • Introduction

  • Site Registration Letters

  • Site submission dossier

  • Siet submission checklist

  • Site Application Forms

  • SMP Validation

  • Site Audit

  • CAPA

  • Renewal

  • What is new?

  • In parallel registration is no longer

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     

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What Will You Learn?

  • 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 "raise, run, and close CAPA".

Course Content

Module 1: Introduction to site registrations
In today’s highly regulated pharmaceutical world, site registration is not just paperwork — it’s your license to operate, import, manufacture, and expand globally. Yet many regulatory professionals struggle with unclear guidelines, incomplete dossiers, authority queries, and costly delays. This course is designed to change that. Whether you're working with manufacturers, secondary packagers, bulk importers, or medical device facilities, mastering pharmaceutical site registration gives you a powerful competitive edge in regulatory affairs.

  • Introduction to site registrations
    13:16

Module 2: Site Registration Letters
Let's prepare Site Registration Letters

Module 3: Site Submission Dossier
Let's prepare the Site Submission Dossier

Module 4: Site Submission Checklist
Site Submission Checklist

Module 5: Site Application Forms
Site Application Forms

Module 6: SMP Validation
SMP Validation

Module 7: Site Audit/CAPA/ Renewal
Site Audit/CAPA/ Renewal

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