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Master Manufacturing Site Registration
Rating: 3.7 out of 5(4 ratings)
24 students

Master Manufacturing Site Registration

Master Pharmaceutical / or medical device site registration with any health authority in any country
Created byDr. Zahra Hassan
Last updated 3/2022
English

What you'll learn

  • 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

Course content

9 sections • 7 lectures • 2h 5m total length

  • Introduction13:33

    This is an introduction to the backbone topic of any kind of health product registration with any health authority in any country, this is an introduction towards the core document for any kind of pharmaceutical/or medical device in any country

    This is an introduction to the manufacturing site registration, the step which couldn't be missed for any kind of product registration

    Together we will answer all questions related to the definition of a site, its checklist, documents, and how to prepare the dossier for its' submission, when it is mandatory and when it is not, for which healthcare products and for which medical-device risk class?

    By the end of this course, you will be able to:

    • Prepare a complete site registration dossier from scratch

    • Evaluate GMP certificates and technical agreements correctly

    • Identify regulatory gaps before submission

    • Reduce approval timelines

    • Position yourself as a regulatory expert in your organization

    So let us start building up our backbone.

  • Site Registration

Requirements

  • Just laptop and willing for improvement

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.

What will you learn?

  • 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 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".

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

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