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U.S. FDA Presubmission (Q-Sub) Program – Requesting FDA Feedback

NSF International
Training overview
2 hours
299 USD
English
Next start date: Inquire for more information - Online

Course description

U.S. FDA Presubmission (Q-Sub) Program – Requesting FDA Feedback

The presubmission or Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. This course provides instruction critical to prepare for a successful meeting with the FDA.

Training Content

Objectives

At the end of this module, you will be able to:

  • Define Q-submissions and the Q-Submission program
  • Recognize when to utilize the program’s mechanisms to get FDA feedback
  • Identify how to apply the guidelines from FDA guidance documents
  • Prepare a quality Q-Submission, that effectively and efficiently conveys the information needed for prescriptive feedback
  • Identify common mistakes in a Q-Submission
  • Engage in a productive discussion with FDA during a face-to-face or teleconference meeting

For more information Visit University Website.

Certification / Credits

Certificate

By completing/passing this course, you will attain the certificate Medical Device Certificate

About supplier

NSF International

NSF International

NSF Health Sciences partners with life science companies, big and small, to provide highly customized end-to-end services throughout the product lifecycle. From early development to commercial manufacture and distribution, our expert services will assist you to: Ensure regulatory compliance Implement...


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