QSR Data and Trending Overlooked FDA Regs That Are Becoming a Top Priority

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An overlooked requirement within the Quality System Regulation (QSR) is quickly moving up the audit checklist of FDA investigators.

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): 

  • March 2011 — Caridian BCT Inc. cited for failure to conduct trend analysis related to CAPA {820.100 cited} 
  • March 2011 — Another warning letter issued to DiaPharma Group Inc., detailed how their formal management review process didn’t include trending of quality data {820.20 cited} 
  • April 2011 — Sometech Incorporated was issued a warning letter that detailed failures to trend nonconformance data {820.100 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.

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:

  • 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

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:

  • 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, 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.

  • QA/QC personnel
  • Manufacturing directors and supervisors
  • Risk management specialists
  • Validation specialists, scientists, engineers
  • Compliance officers
  • Training personnel
  • Executive management
  • R&D staff
  • Regulatory affairs professionals
  • General/corporate counsel
  • Consultants/service providers

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.

Register now!

Date: Sept. 19 – Oct. 7, 2011
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