The way drug and biologics concerns report quality metrics data to the FDA is about to change for good. A regulation nearing finalization will affect every company large and small that manufactures, prepares, propagates or compounds active ingredients or pharmaceutical products produced and sold in the U.S.
It’s vital to find out what’s in this reg-to-be — before it’s set in stone.
FDAnews has assembled a panel of industry experts and former FDAer with an inside track to the answers. You can participate without ever leaving your office.
Tune in for an advance look at this key regulation. You’ll discover:
- How the final guidance will affect your operations
- How the FDA intends to use the data collected
- Who is required to comply — and who isn’t
- Which data you must report, which you can safely skip
- When the data must be reported, how it must be submitted
- What’s happening with the PDA’s Quality Assessment Tool pilot program
- And much more!
Your presenters include former senior FDAer Denyse Baker, Susan Schniepp of Regulatory Compliance Associates Inc., and Amgen’s Cylia Chen Ooi. These three experts — with more than 70 years experience combined — are sharing their insider knowledge on what quality data collection really means to you.
In a fast-paced hour and a half, they’ll deliver an overview of the guideline, details on specific quality metrics being requested and advise you on how to use this information to improve your firm’s compliance position with the FDA.
They will also discuss PDA’s Quality Culture Assessment Tool pilot program which is intended to help companies advance their overall quality culture. Using the tool, assessors will look at various aspects of a manufacturing site to determine how mature the quality culture is.
The final reg will be out before you know it. Seize this opportunity to get an advance look from people who know what they’re talking about.