Continuing Education Credits are not available for the archived offering.
This program is a part of DIA's Certificate Program and is awarded the following:
Regulatory Affairs Certificate Program: 2 Core Units
For more information go to www.diaglobal.org/certificateprograms

This archive may be purchased through July 16, 2016.
Archive duration:
1 hour 54 minutes

Establishing a good working relationship and open communication with the FDA is essential to the development of any regulated product. To ensure efficient communication, FDA has established very specific and formal ways for the industry to interact with FDA personnel. It is critical that every regulatory affairs professional, as well as other project team members, understand these methods of communication with FDA and how to use them appropriately and effectively.

You will learn the various methods for communicating with the FDA, including telephone calls, emails, faxes, and meetings.  Special attention is given to the types of formal FDA meetings available to industry, as well as specific details on how and when to request them.  Finally, you will receive specific recommendations, based on the experience of leading regulatory affairs professionals, on how to conduct successful and productive meetings with FDA.

Course Level: Beginner