Streamlining Business Processes for Efficient eCTD
|
|
|
|
Workshop Length
Instructor-led 1-day workshop |
|
Cost
$995
Overview
A one month deadline to submit your NDA application to the regulatory agency is fast approaching, and you only have 300 man hours. You still need to add all internal hyperlinks, add documents to their proper placement in the eCTD and create the external hyperlinks. How do you get all this done in time with only the resources that you have?
This one-day workshop takes years of field-tested experience and distills it into practical, easy-to-implement solutions. Participants will learn how to analyze their current business process, learn best practices for submission management, and analyze their current technical infrastructure to address environmental constraints. Participants will come away with valuable knowledge and insight into managing efficient eCTD business processes.
The Streamlining Business Processes for Efficient eCTD workshop is lead by expert consultants and trainers who have masterful knowledge of eCTD and regulatory submissions. Our trainers have presented at industry conferences, authored publications and written courses and textbooks on eCTD and other industry topics. With over 400 successful eCTD submissions, ISI is committed to passing on field-tested experience and best practices to workshop participants.
Workshop Details
Who Should Attend
This workshop is designed for managers, administrators and IT support personnel responsible for regulatory submission business processes, including professionals in regulatory affairs, dossier management, document management, data management, compliance and medical writing.
Prerequisite
- Successful completion of eCTDXPress 204: eCTDXPress Full System Training and ISIPublisher 101: ISIPublisher Basic Training are strongly recommended
- Knowledge of existing business processes
- Basic knowledge of regulatory submissions process
Workshop Materials
A Streamlining Business Processes for Efficient eCTD Workshop training guide is provided with detailed information and examples based on consulting experience.
Workshop Learning Objectives
After attending this workshop participants will have had the opportunity to:
- Learn how to optimize current business processes.
- Understand the technological considerations of implementing business processes for eCTD.
- Learn best practices on how to leverage current resources.
- Learn how to implement solutions along the business process continuum for greater efficiency.
Lesson Topics
- Current Business Process Analysis and Discussion
- Best Practices: eCTD Process Overview
- Best Practices: Effective Hyperlinking
- eCTD Lessons Learned
- Best Practices: Submission Management
- Technical Check: System Architecture and Administration
- Business Process Finalization
|
|
|