Your cart is empty.
Keep shoppingPharmaceutical regulatory affairs CTD course
13 students
Pharmaceutical regulatory affairs CTD course
Common technical documents ICH GCC sFDA
Created byMoshira Abbas Elmazahy
Last updated 10/2025
English
What you'll learn
- Each trainee will be able to to prepare a registration file of pharmaceutical product according to a CTD format
- Learn details about DMF, COS, CEP, LOA Know ICH guidelines concerning to preparation of CTD file.
- Know Cmc chemistry manufacturing and control
- Know ICH guidelines concerning to preparation of CTD file.
- Know Cmc chemistry manufacturing and control
- Submit CTD file to different regulatory authorities upon their request.
- Prepare a registration file according to the CTD format in accurate, precise & saving time manner.
- Cooperate with different departments involved in preparing CTD file.
- Review the CTD file before the submission of file to the authority and reply to any comments or requirements of different authorities.
Explore related topics
Course content
4 sections • 15 lectures • 1h 28m total length
Requirements
- No requirements
Description
Section 1
-Introduction to Common Technical Document (CTD)
-Definition of CTD
-History of CTD
-Background on ICH guidance and CTD
-Benefits of CTD
-General principle of CTD format
-Basic structure of CTD (module 1-5)
-Naming of each module
-CTD triangle
-Workshop
Section 2
-Module III Quality (Drug Product)
CMC(chemical manufacturing control)
-Description and composition
-Pharmaceutical development
Formulation development
Manufacturing process development
Comptability
Critical steps
Manufacturing process ad flow chart
Process control
Procees validation
-manufacture
-Control of excipients
Specification
Analytical method
Validation of analytical method
Justification of specification
Novel excepient
-Control of drug product
Specification
Analytical method
Validation of analytical method
Justification of specification
Characterization of impurities
Batch analysis
-workshop
Section 3
The rest of quality module (Module 3 product)
-Reference standard, SDS, COA
-container closure system primary and secondary packaging materials
-Stability study
-Appendices & Regional information from Uganda and GCC
Alcohol content
Excepients from animal or human origin
Coloring agents and diluents
Difference between master production documents and batch manufacturing record
*Workshop
Section 4
-Module III Quality (Drug substance)
-Details information about DMF of
active substance and its contents
according to CTD format
-details about COS, LOA
-General information of API
-Manufacture
-Characterization
-Control of drug substance
-Reference standard
-Container closure system
-Stability study
-Ho can you prepare a CTD file
Who this course is for:
- Fresh graduated pharmacist, chemist & veterinary
- Experienced pharmacists, chemist &veterinary who are want to make shift career
- Regulatory affairs
- Supply chain
- Quality control
- Research and development
- pharmacist, chemist& veterinary who are working in pharmaceuticals industries such as
- Common technical documents ICH GCC sFDA