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FDA Presubmission Program – Requesting FDA Feedback

NSF International, Pharmaceutical Services
Course summary
2 hours
299 USD
English
Online courses
Next available date: Enquire for more information - Online courses

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.

Outcome / Qualification etc.

Certificate

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

Why choose NSF International, Pharmaceutical Services

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert pharmaceutical training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider

Expenses

Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

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About provider

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...


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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York

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