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An IS0 9001:2015 Certified Institute

Quires & Approval Changes

Quires & Approval Changes

About the course:-

In order to attain the drug product approval from the agencies any quires/ deficiencies need to be effectively responded to gain the approval. After receiving the approval or during commercialization of the drug product, if manufacturers realize and propose any changes (administrative/quality) to the registered content (that is dossier), those shall be informed to Health Authority (HA) by filing supplements or variations or amendments, which are referred as post-approval changes. Based on the impact, these changes are categorized further according to agencies.

Objective of the course:-

THIS COURSE IS BEST SUITABLE FOR REGULATORY QUIRES/DEFICIENCES FILINGS &POST APPROVAL CHANGES

Course Syllabus

Course Features

Instructor Live Sessions

There will be allocated hours of instructor with Live classroom and Simultaneously on Online.

Real Time Studies

Live project based on any of the selected use cases on the above selected Domain.

Assignments

Each class will be followed by practical assignments which can be completed before the next class.

24/7 Support

We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.

Certification

Towards the end of the course, you will be working on a project. Sadhana Infotech certifies you as an course Expert based on the project.

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