Continuing Education credit or Certificate Program units are not available for Archived Webinars
Companies of all sizes will need to comply with FDASIA mandates for electronic submissions. While many companies have already begun this transition, many small companies and freelancers are facing these pending requirements with less resources and foundational knowledge. This webinar is focused on the medical writing tools and skills needed for creating eCTD and eCopy format submissions to FDA. This webinar is not focused on later steps of eCTD assembly and publishing, but on the myriad skills and tools needed to prepare e-submission-ready documents. The webinar will conclude with discussion on the various IT options for electronic submissions and the various deployment approaches including a full license, pay-per-submission models, and cloud environments.
This archive webinar will be available for purchase through November 30, 2014.
- eSubmission-friendly document authoring skills and tools
- PDF remediation skills and tools
- Established and emerging IT options for eSubmission capability
Who should attend?
Professionals involved in:
- Information technology
- Medical writer/editor
- Regulatory writer/editor
- Regulatory operations specialist
At the conclusion of this webinar, participants should be able to:
- Recognize MS Word tools that enable generation of eSub-compliant PDFs
- Explain FDA’s PDF standards and PDF remediation approaches to meet those standards
- List vendor options for eSubmission IT solutions (for eCTD, eCopy) and of various deployment options