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Electronic communication between USFDA and Applicant
Requirements
Pharmacy Profession
Regulatory affairs associate
Pharmaceutical industry Background
Curiosity towards learning
Science education
Description
If you Regulatory affairs profession and you are not aware about ESG (Electronic Submission gateway, then this course will make you specialist in handling regulatory hurdles. You can easily get Approval for your registered product in less time.
The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions.
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We upload these learning materials for the people from all over the world, who have the talent and motivation to sharpen their skills/ knowledge but do not have the financial support to afford the materials. If you like this content and if you are truly in a position that you can actually buy the materials, then Please, we repeat, Please, Support Authors. They Deserve it! Because always remember, without "Them", you and we won't be here having this conversation. Think about it! Peace...
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FILE LIST
Filename
Size
~Get Your Files Here !/01 - Introduction/001 Introduction.mp4
32.8 MB
~Get Your Files Here !/01 - Introduction/002 Overview of Registration Process.mp4
39.9 MB
~Get Your Files Here !/02 - Preparatory Activities/001 Letter of Non Repudiation Agreement.mp4
32.6 MB
~Get Your Files Here !/02 - Preparatory Activities/002 Obtaining Digital Certificate.mp4
38.3 MB
~Get Your Files Here !/02 - Preparatory Activities/003 Understand Submission Guidelines.mp4
50.3 MB
~Get Your Files Here !/02 - Preparatory Activities/004 Naming Conventions.mp4
6.1 MB
~Get Your Files Here !/02 - Preparatory Activities/005 Determine Submission Methods.mp4
42 MB
~Get Your Files Here !/02 - Preparatory Activities/006 Connection Requirements.mp4
18.1 MB
~Get Your Files Here !/02 - Preparatory Activities/39858010-ADI-Definitions-0.pdf
148.3 KB
~Get Your Files Here !/02 - Preparatory Activities/39858054-FDA-ESG-ADI-Dashboard-Pocket-Guide.pdf
322 KB
~Get Your Files Here !/02 - Preparatory Activities/external-assets-links.txt
1.4 KB
~Get Your Files Here !/03 - FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS/001 FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS.mp4
57.7 MB
~Get Your Files Here !/03 - FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS/39858160-Registering-for-an-AS2-test-account.docx
274.6 KB
~Get Your Files Here !/03 - FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS/39858198-Sending-a-WebTrader-Test-Submission.docx
863.5 KB
~Get Your Files Here !/03 - FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS/39858218-Registering-for-a-WebTrader-Test-Account.docx
304.2 KB
~Get Your Files Here !/03 - FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS/external-assets-links.txt
129 B
~Get Your Files Here !/04 - Congratulations and Thank you/001 Congratulations and Thank you.mp4
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