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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):
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.
Well, 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.
That’s why you should attend QSR Data and Trending, a fast-paced, fact-packed 90-minute webinar from FDAnews being held on Tuesday, Sept. 13. From the comfort of your own office, you’ll discover:
The FDA audit development
that’s taking everyone by surprise
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 one. Complaint Files, 820.198 is another.
That’s why FDAnews has invited James Eric Miller, senior quality analyst in core quality 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, Sept. 13 and Mr. Miller will share timely and actionable QSR specifics with you, like:
Everyone in your organization with a role in QSR deserves to take part in this event — and they can, 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.
So, sign up today for QSR Data and Trending: Overlooked FDA Regs That Are Becoming a Top Priority on Tuesday, Sep. 13.
James Eric Miller is the senior quality analyst, core quality systems at Roche Diagnostics. Mr. Miller is a quality data subject matter expert for CAPA, nonconforming products, local level and escalated-level complaints. He provides functional area specific and sitewide quality metric scorecards andrend analysis. Additionally, he provides statistical and sampling consulting and training. Mr. Miller manages a leading group of engineers and technicians in a high-volume, fast-paced manufacturing environment. He is highly skilled in new product introduction project management, statistical and quantitative analysis, problem solving and Lean. He previously worked for Thomson Consumer Electronics and Ciba-Corning Diagnostics. He has a BS degree from the U.S. Military Academy, with a concentration in operations research, and a master’s in business administration from Ball State University.
|Date:||Sept. 19 – Oct. 7, 2011|
|Location:||Your office or conference room (no need to travel!)|
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