Overview

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 RenewalThis 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 AuthorizationAnnex II List of Medicinal Products and APIsAnnex III GMP CertificatesAnnex IV List of Subcontractors Annex V Organization Chart, Duties, CVsAnnex VI Layout Annex VII Schematic DrowningsAnnex VIII Equipment's list, FP, API, CQThen 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

Skills

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