Course description
FDA Presubmission Program – Requesting FDA Feedback
The Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. The idea behind the Q-Submission program is not new and in fact, has often been a critical part of premarket review. However, a comprehensive system for FDA feedback mechanisms had not been well-defined prior to FDA's recent guidance documents issued in 2017 and 2018. In this course we will review these guidance documents and the recommendations provided within to make your next request for FDA feedback more effective and productive.
Upcoming start dates
Outcome / Qualification etc.
Certificate
By completing/passing this course, you will attain the certificate Medical Device Certificate
Training Course Content
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
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.