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An IS0 9001:2015 Certified Institute

E-CTD TRAINING

E-CTD TRAINING

About the course:-

The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).

Objective of the course:-

THIS PROGRAMME HELPS TO UNDERSTAND E-CTD SUBMISSION AND ITS REQUIREMENTS

Course Syllabus

Topic : 1 Learning Outcome

Topic : 2 Course Structure

Topic : 3 Validation

Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages.

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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