Course Description

Good Documentation & Writing Practices for Regulatory Submissions

Course Description:

The focus of this course is to describe the steps in preparing a regulatory submission for a medical device in the United States. The overview of the process steps are:

  • Regulatory Submission Basics
  • Submission Planning
  • Submission Writing
  • Supporting Documents and Data
  • Lifecycle Management

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Learning Objectives:

After taking this course the trainee should know the key concepts:

  • The writing of a regulatory submission is not a solitary activity,
  • Communication of commitment made to regulators must be kept,
  • Good documentation and best writing practices streamline this interactive process.

Who Should Enroll:

Any medical device professional responsible for writing and or reviewing US Regulatory Submissions.


Prerequisite Knowledge/Requirements:

None


Subject Matter Expert:
Georgiann Keyport

Duration:
60 min

Release date:
09/01/2010

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 234.00
Premium Account: € 176.00

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