Unexpected Questions & Issues During the Regulatory Submission Process
Learn what next steps to take when unexpected questions and issues arise during the regulatory submission process. In this one-hour webinar, Managing Challenging Submissions, you will learn how to:
- Minimize the risk of receiving a RTA Notification, Deficiency List, and / or AI Letter
- Respond to FDA communications regarding your regulatory submission
- Facilitate discussions with the Lead Reviewer for the regulatory submission
- Leverage recent FDA guidance documents and recognize FDA trends that may impact your regulatory submission
- Solicit and engage cross-functional support with engineering, quality, and new product development teams