Teaching & Academics Online Course by Udemy, On Sale Here
Pharmaceutical eCTD & CTD Preparation & Submission
An excellent training about Science
eCTD & CTD Preparation & Submission Course
The eCTD specification has been developed to facilitate the Global electronic Submission, Review and Lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format. This online course details the Electronic Common Technical Document specification, provides guidance on the creation of the submission of an eCTD, and discusses the approach to regional differences in dossiers. This relatively fresh aspect of submissions will undergo significant and rapid changes as specifications are refined and modified further. This class is a superb training tool and reference and can be of assistance to anyone involved with electronic submissions and in navigating these changing requirements. Once all course requirements have been satisfied, a certificate of completion is immediately available. Learning OutcomeBasic Understanding of CTD & eCTDAssisting in Compiling & filling and eCTD ApplicationIdentifying EU & US Requirement for eCTDTransiting from Paper based Submission to eCTD SubmissionReview eCTD ApplicationCourse StructureIntroduction & Overview of CTDCTD Fundamentals ( Module 1 – 5)eCTD Fundamentals & DetailsBest Practice in Preparing eCTDSubmission using eCTD FormatLife Cycle Management for eCTDeCTD Software for Compilation & ValidationWho will Benefit QC/QA Managers & StaffDocumentation DepartmentRegulatory Affairs Department – Responsible for CTD /DMF Preparation & SubmissionResearch Chemist, Quality Control Chemist, CRO’s involved in DocumentationPharmacy Graduates with knowledge of CTDAny science graduates who are seeking job opportunities in Regulatory AffairsTeaching MethodologyParticipants will be provided with course & study materialPractical Training will be provided on eCTD. Paritcipants can ask their query/questions to the instructor during the course. Benefits of Getting Certified then job opportunities asRegulatory Affairs AssociatesRegulatory Affairs AssistanceRegulatory Affairs Head/ DirectorMedical Information AssociatesDrug Inspector/Drug ControlleDrug Safety Specialist/ Regulatory Food Safety ScientistQuality Operations/Quality Control/Quality AssuranceEligibilityLife Science Graduates with Experience or Knowledge of Regulatory Affairs
Udemy is the leading global marketplace for learning and instruction
By connecting students all over the world to the best instructors, Udemy is helping individuals reach their goals and pursue their dreams.
Study anytime, anywhere.