Develop the skills you will need to progress into the electronic age for medicines registration.
2-day training program.
Small focused groups.
One tutor to a maximum of 4 delegates.
Comprehensive electronic environment provided for hands on experience.
This software independent training uses a variety of software tools and will cover the following:
- Reviewing standards and regulations involved in eCTD and submissions;
- Setting up the electronic document environment necessary for eCTD;
- Meeting ZA specific and ICH requirements for the electronic dossier;
- Keeping control of electronic documents and dossiers for the life cycle of the product;
- Hands on:
- Creation of a ZA eCTD from an international CTD supplied as electronic documents.
- Authoring and Working with electronic documents and ensuring compliance for eCTD submission.
- Applying the South African Validation criteria. Technical Validation and problem solving.