Webinar On The FDA 510(k) and Q-Submission: Best Practices
February 4, 2015 - Mississauga ON CACompliance Trainings
suzzane.d@compliancetrainings.com
Phone:4169154438
This webinar will provide an opportunity to get familiar with an FDA's process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss how to put together a pre-submission (Q-submission) to obtain FDA feedback on your proposed questions, which will be helpful and useful for your device design, preclinical and clinical study plan and design, if applicable. The speaker will discuss contents and format for a Q-submission and 510(k)compliant with the FDA's eCopy and RTA policy, helping you streamline your dialogue with the FDA for maximum benefits while preparing for a 510(k) submission in a least burdensome, effective manner. In this webinar, the speaker will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared. This webinar is a must for regulatory professionals working in medical device industry including those who are interested in the topic.