NEWLY UPDATED!

Course Description:

In January 2015 FDA opened its Office of Pharmaceutical Quality (OPQ) with the goal of "creating a drug quality program as robust as the programs the agency already has in place for drug safety and efficacy."  This new office released the draft guidance “Request for Quality Metrics” in July 2015.  When final, this guidance will ask firms to submit quality data directly to FDA across a wide spectrum of metrics.  The agency will then take this data and map it to a risk matrix that they will use to determine if your firm is ripe for inspection.  Firms that have robust data collection systems will be in the driver’s seat to compliance.  Those that don’t are at risk of inspection and all the setbacks that come with it.

This newly updated session will include information on feedback from industry and other developments since the guidance issued.  Plus, this session will provide a variety of sources of information that you and your colleagues can use to determine how this guidance may affect your existing operations.

Join us for this interactive, 90-minute session to learn:

• What data the FDA is proposing to require
• Who needs to report, and what needs to be reported
• How many reports should be submitted
• What will happen in the case of non-reporting
• What are the challenges
• Feedback from industry and current status of the initiative
• Critical steps to prepare for any eventuality