QSR Data and Trending Overlooked FDA Regs That Are Becoming A Top Priority
Product Details
QSR Section 820 doesn’t mention the word “trend,” but the FDA has demonstrated in 483s and warning letters that it expects companies to analyze and trend their quality data — and then act on what they’ve learned.
But most companies don’t know the scope of the requirements, let alone how to react to them.
Is yours one of them?
You won’t find it in the Quality System Regulation (QSR) Section 820.
But you will increasingly find it in FDA warning letters. Since 2009, warning letter citations make clear that it’s no longer enough for you to look back at the data and then react to quality problems.
You are now expected to trend your quality data.
In fact, the FDA wants you to maintain a 24/7 state of control by proactively monitoring your quality systems. And compliance isn’t optional, despite the fact that your information sits isolated in “data silos” like complaints and OOS — making your task of identifying trends nearly impossible.
How serious are they? Consider just three recent examples (with emphasis on trend added):
- January 2010 — Crown Health Care Laundry Services, Inc. cited for failure to: “document CAPA activities, i.e. trend analyses...” {820.10 cited}
- May 2009 — warning letter to Howard Instruments: “Your firm had no documentation to demonstrate any trend analysis had been conducted in the past three years.” {820.20 cited}
- January 2009 — warning letter to Hammill Manufacturing: “Failure to analyze and trend nonconformances, complaints, and other sources of quality data...” {820.10 cited}
Maybe you’ve already mobilized but need to fully understand the scope of the QSR. Or you’re unsure where to start, and want a playbook on setting up a quality and data trending system. You know the sooner you do, the more stable and useful your information will be — substantially improving your odds of passing the FDA’s new QSR audit challenge.
Get what you need in QSR Data and Trending, the fast-paced, fact-packed 90-minute webinar from FDAnews on Tuesday, March 16. From the comfort of your own office, you will discover:
- How to scrutinize quality data on a routine and established basis
- Which statistical methodology evaluates data most accurately — and how to best apply it
- The 5 best practices for organizing your “data silos” — and how to validate them
- How to spot quality problems more quickly — the quality data dashboards that improve your trending
There’s more. And due to another surprising
FDA audit development, you’ll need to know even more.
No matter your company’s area of expertise — medical device, diagnostic or contract manufacturer, or supplier/outsourcing organization — you should know that agency citations are being derived right now, indirectly from regulations that may not even be on your radar screen. Production and process controls, 820.70(a), is but one. Complaint Files, 820.198 is another.
That’s why FDAnews has invited James Eric Miller, senior quality analyst in core auality systems at Roche Diagnostics — and a quality data subject matter expert for CAPA, non-conforming products, local level and escalated level complaints — to be your webinar leader.
Attend QSR Data and Trending on Tuesday, March 16 and Mr. Miller will also share timely and actionable QSR specifics with you, like:
- A complete analysis of applicable QSR and GHTF regulations and guidances — how direct (and indirect) regulations should guide your planning
- Lessons learned from the mistakes of others — an in-depth look at recent Form 483s and warning letters to pick up on what investigators are targeting and what citations they use
- 3 tips on conducting specific problem concern deep dives and cross-data source searches
- And more — you’ll even have a chance to ask your toughest QSR questions ...
Everyone in your organization with a role in QSR deserves to take part in this event — and they can do so, at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.
This is a workshop you attend without leaving your workplace. Simply make sure you’re in front of a screen at the appointed time. Have questions? Submit them via email for answers by the time the session ends.
Mark your calendar now for the 90-minute webinar, QSR Data and Trending, on Tuesday, March 16.