Conducting Successful FDA Meetings

Virtually every medical device firm and pharmaceutical firm will need to meet with FDA at some time.  To be prepared for these meetings and know how to handle them can be critical to the success of your business.  Communicating with FDA to determine as much a possible about their expectations regarding product submissions, clinical study design, corrective actions and other regulatory requirements is a challenge for every regulated business, but critical for drug and device firms.  FDA has formalized this meeting process and this webinar will help prepare you to handle the FDA requirements for meetings and conduct successful meetings.

Why Should You Attend | Online corporate training Webinars

If you will participate in meetings with FDA you must know what to expect, and how to prepare in order to achieve the desired  outcome

Objectives of the Presentation 

•  Become familiar with the types of FDA persons who conduct meetings with Industry
•  Know the type of questions appropriate to ask FDA, and inappropriate to ask FDA
•  Prepare well and gain a result that benefits your company and meets FDA’s expectations

Areas Covered in the Session | Online Training Portal for professionals

•  Requesting the meeting
•  Preparing an agenda for the meeting
•  Know who should attend the meeting representing your firm
•  How to prepare your team for the FDA meeting
•  How to serve as the central spokesperson of your team at the FDA meeting
•  How to judge your success after the FDA meeting
•  Preparing a meeting summary for FDA

Who Will Benefit | AbideEdict Training for Professionals

•  CEO’s
•  COO’s
•  General Managers
•  Senior Executives from key company functions
•  Regulatory Professionals
•  Quality Assurance Professionals
•  Internal quality auditors
•  Industry consultants who work with FDA regulated firms