Develop essential engineering skills with expert instruction and practical examples.
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 RenewalWhat is new.
In parallel registartion 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.
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