ISIWriter Master Certification
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| Date |
Location |
| June 19 - 20 |
Whippany, NJ |
| July 31 - August 1 |
San Diego, CA |
| August 21 - 22 |
Whippany, NJ |
| December 4 - 5 |
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
ISIWriter is a powerful set of templates that helps Medical Writers and industry professionals author regulatory compliant documents. Using scenario based processes, this workshop guides participants through best practices and methods for building a workflow around the usage of templates when working with ISIWriter.
Participants will discuss current business requirements, gain mastery of full ISIWriter functionality, and learn about the template customization process and methods to implement your business process. In addition, participants will learn how to maximize efficiency and save time with short cuts, and will be able to test their knowledge with a culminating Master Certification exam.
Workshop Details
Who Should Attend
This workshop is designed for anyone using ISIWriter to author documents, create templates and administer the ISIWriter system, including Medical Writers, Managers of Publishing Departments, Publishers and Regulatory Affairs Personnel.
Prerequisite
- Knowledge of guidance related to document authoring
- Knowledge of eCTD granularity a plus, but not required
Workshop Materials
An ISIWriter Master Certification Workshop training guide is provided, along with a scenario-based workbook that allows participants to see how ISIWriter 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 ISIWriter functionality to specific regulatory scenarios and tasks. Upon passing the exam, participants will receive ISIWriter Master Certification.
Workshop Learning Objectives
After attending this workshop participants will have had the opportunity to:
- Understand the regulatory guidance that surrounds authoring submission documents.
- Understand how to apply best practices and short cuts to save time and maximize efficiency.
- Better understand electronic regulatory submission preparation.
- Understand the template customization process and methods to implement within your business process.
- Understand how to share documents and incorporate review cycles into document authoring.
- Underhand how to incorporate ISIWriter styles into other documents.
Lesson Topics
- Understanding Current Business Requirements
- ISIWriter Components and Architecture
- ISIWriter Customization and Management
- Publishing Considerations
- Populating Document Information Fields
- Working with Heading Styles
- Working with Body Text
- Working with Special Styles
- Working with Figures and Tables
- Working with Landscape Sections
- References and Citations
- Creating and Deploying Site Customization Templates
- Modifying Existing Content Templates
- Creating New Content Templates
- Creating and Modifying Document Information Fields
- Working with Drop-Down Lists
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