Good Technical Documentation
Online Training Course for Self-Paced Learning.
The high quality of technical submission dossier is one of the key factors for an efficient and successful regulatory submission.
Tools and Learning Techniques
If you are interested to register for the workshop, please contact us at firstname.lastname@example.org.
Please indicate whether you are interested to register for an individual use or for a team.
Web-based interactive training course with various lessons and supporting information and documentation for self-paced learning.
The objective of the online training course it to increase the skills of writing scientific-technical documentation
Staff members of Drug Regulatory Affairs departments concerned with writing scientific technical documentation
- Dr. Nanni Jelinek, Jelinek Scientific Documentation GmbH
- Dr. Barbara Jentges, Phact GmbH
The high quality of technical submission dossier is one of the key factors for an efficient and successful regulatory submission. The following topics will be covered in various lessons:
Demand for efficient and high quality regulatory submissions
- Efficient and successful regulatory submissions – a “key” for time-to-market
- Regulatory challenges and regional hurdles
- What makes a good regulatory document
- MS WORD and file formatting
- File settings and file properties: Creating eCTD-compliant PDFs
Transferring source data into compliant quality documents
- Source documents: Scientific, technical and GMP documents as solid basis for Module 3
- In-depth comparability of source documents and CMC chapters
- Common challenges regarding internal and external source documents – and solutions
- From plan to archive: The history of a report
- CMC Parameters in a Style Guide
Best practices on how to present quality data
- Tools for presentation of quality data
- General considerations regarding numbers, font and captions
- Structure and design of clear tables – examples from Module 3
- Graphs as broad tool for data presentation – examples from Module 3
- Data transfer from analysis software to Word document
Key factors for a successful regulatory submission project
- The regulatory submission – a complex project under time pressure
- Optimizing the workflow of data, documents and tasks
- How to benefit from collaboration and shared-knowledge platforms
- Review cycles: How to avoid the “infinite loop”
- How to measure “success” and make continuous improvements
The course participants will benefit from various worksheets and templates for download:
- eCTD-compliant submission document template in Microsoft® WORD®
- Style Guide for Regulatory Submission Documentation in Microsoft® WORD® and in Portable Document Format (PDF)