ISIToolBox Master Certification
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| Date |
Location |
| March 13 - 14 |
Whippany, NJ |
| May 22 - 23 |
San Francisco, CA |
| July 17 - 18 |
Whippany, NJ |
| September 25 - 26 |
San Diego, CA |
| October 23 - 24 |
Whippany, NJ |
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Workshop Length
Instructor-led 2-day workshop |
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Cost
$1195 (Register 4 people and get the 5th free)
Overview
ISIToolBox is a powerful suite of tools for Life Science professionals involved in regulatory document preparation. This comprehensive two-day workshop prepares participants with mastery of the tools and functions of ISIToolBox in relation to specific regulatory documents and scenarios.
Workshop participants will learn how to facilitate and expedite the electronic publishing process. Through best practices and case examples on how to save time and boost efficiency, participants will learn how to unleash the full potential for over 100 ISIToolBox tools. In addition, participants will be able to test their knowledge with a culminating Master Certification exam.
Workshop Details
Who Should Attend
This workshop is designed for Life Science professionals responsible for electronic publishing, and desire to learn how to use ISIToolBox tools with specific document types.
Prerequisite
- Knowledge of existing business processes
- Basic knowledge of regulatory submissions process a plus, but not required
- Basic knowledge of Adobe Acrobat functions
Workshop Materials
An ISIToolBox Master Certification Workshop training guide is provided, along with a scenario-based workbook that allows participants to see how ISIToolBox tools can be applied to real examples of submission documents.
Certification
This course culminates in a certification exam which consists of two parts: a hands-on assessment and written exam. This certification exam tests participants’ abilities to apply ISIToolBox functionality to specific regulatory scenarios and tasks. Upon passing the exam, participants will receive ISIToolBox Master Certification.
Workshop Learning Objectives
After attending this workshop participants will have had the opportunity to:
- Understand regulatory guidance surrounding PDFs.
- Understand how to apply tools to specific regulatory scenarios and tasks.
- Understand how to apply best practices and short cuts to save time and maximize efficiency.
- Better understand electronic regulatory submission preparation.
Lesson Topics
- Regulatory Guidance Surrounding PDFs
- Bookmarking and Hyperlinking Submission Documents (CRFs, Summaries, CMC documents, CSRs, nCSRs, etc.)
- Processing Text-Based vs. Image-Based PDF Documents
- QC and Submission Finalization
- Paper Submission Formatting
- Targeting PDF Documents For Specific Submission Types
- Creating, Modifying and Managing Bookmarks and Hyperlinks
- Bookmark and Hyperlink QA
- Working with Named Destinations
- Modifying Document Properties
- Importing and Exporting PDF Document Information and Attributes
- Copying Text and Graphics
- Enhancing PDF Image Quality
- Adding Page Numbering and Stamping Information to PDF Documents
- Using Batches to Automate Common Tasks
- Using ISIToolBox to Meet Regulatory Requirements
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