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The Silver Sheet
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   Full-text available via subscription Subscription journal
     ISSN (Print) 1068-5324
     Published by Informa plc Homepage  [13 journals]
  • 4 Gaps In QSIT That, If Bridged, Will Better Focus FDA Inspections
    • Abstract: Online-Only Content >>> FDA’s Quality System Inspection Technique should be reviewed to address so-called gaps in the 15-year-old audit approach, including supplier controls, says the former leader of the agency’s QSIT team. Other QSIT soft-touch areas include design transfer, management controls and CAPA.
      PubDate: Thu, 04 Dec 2014 11:05:02 -050
       
  • PODCAST: Using QSIT As A Learning Tool
    • Abstract: Online-Only Content >>> Tim Wells, former team leader for FDA’s Quality System Inspection Technique and coauthor of the agency’s QSIT handbook, explains how medical device firms can use the inspectional approach as a learning tool in this “Silver Sheet” podcast.
      PubDate: Mon, 17 Nov 2014 10:51:00 -050
       
  • PODCAST: 5 Ways Firms Can Use QSIT For Internal Quality Audits
    • Abstract: Online-Only Content >>> In this new “Silver Sheet” podcast, Denise Dion, part of the team that wrote FDA’s Quality System Inspection Technique, offers quick tips for medical device manufacturers on how they can use QSIT when performing internal audits.
      PubDate: Mon, 17 Nov 2014 10:50:00 -050
       
  • Warning Letter Roundup & Recap
    • Abstract: bioMérieux closed nearly nineteen thousand complaints without conducting thorough investigations; Cook scrapped more than half a million devices between 2012 and 2014 – but didn’t use that information as a source of CAPA quality data. Eight quality-related warning letters were listed by FDA from Oct. 15 through Nov. 11.
      PubDate: Wed, 12 Nov 2014 13:00:07 -050
       
  • CDRH Seeks To Fill Science Post
    • Abstract: CDRH is on the hunt for a director to lead its newly created Division of Biology, Chemistry and Materials Science in the Office of Science and Engineering Laboratories.
      PubDate: Wed, 12 Nov 2014 13:00:06 -050
       
  • QSIT At 15: Two Co-Creators Of FDA’s Aging Audit Technique Look Back
           – And Mull Over Today’s Agency Approach
    • Abstract: Now that FDA’s Quality System Inspection Technique is 15 years old, is it time for a facelift? Two ex-FDA officials who were part of the FDA team that developed QSIT say the inspectional approach is still relevant, but perhaps for different reasons than were envisioned in 1999.
      PubDate: Wed, 12 Nov 2014 13:00:05 -050
       
  • Accelerated Device Reform In Europe'
    • Abstract: Members of the European Parliament have voted overwhelmingly in favor of starting negotiations with the Council of the European Union on the European Commission’s proposed comprehensive regulatory reform for medical devices and in vitro diagnostics.
      PubDate: Wed, 12 Nov 2014 13:00:04 -050
       
  • Increased Oversight Of FDA Coming, Industry Attorney Warns
    • Abstract: Now that the election is over and Republicans will soon run Congress, expect GOP members to push for FDA reform, a Latham & Watkins partner predicts.
      PubDate: Wed, 12 Nov 2014 13:00:03 -050
       
  • Protecting Legacy Devices From Cyber-Attacks A Concern
    • Abstract: While FDA is nudging device companies to do more to protect their interconnected or wireless devices from cyber-attacks, they still struggle with advising device firms and users on how to protect legacy devices from system breaches.
      PubDate: Wed, 12 Nov 2014 13:00:03 -050
       
  • Recent Warning Letter Close-Outs
    • Abstract: Four quality-related FDA close-out letters were released from Oct. 15 through Nov. 11.
      PubDate: Wed, 12 Nov 2014 13:00:02 -050
       
  • Don’t Be Haunted By Making Poor Post-Market Surveillance Choices
    • Abstract: Online-Only Content >>> For a Halloween treat, GE Healthcare’s Patrick Caines returns to “Compliance Corner,” this time to dole out advice on post-market surveillance quality data inputs and the outsourcing of complaint collection.
      PubDate: Fri, 31 Oct 2014 13:45:00 -040
       
  • No FDA Warning Letters For Device Firms Participating In IMDRF
           Single-Audit Pilot
    • Abstract: Online-Only Content >>> Warning letters will not be issued to manufacturers that volunteer to be inspected under the International Medical Device Regulators Forum’s single-audit pilot program unless a significant threat to public health is uncovered, CDRH official Kim Trautman says.
      PubDate: Thu, 23 Oct 2014 15:25:00 -040
       
  • Avoid These 5 MDR Pitfalls
    • Abstract: Online-Only Content >>> GE Healthcare’s director of product surveillance, Patrick Caines, warns manufacturers about five Medical Device Reporting traps that can cause regulatory and enforcement headaches, including poor data input and analysis, halfhearted investigations, and an unhealthy MDR system.
      PubDate: Tue, 21 Oct 2014 11:15:03 -040
       
  • GUEST COLUMN: New AdvaMed ‘Library Of Successful Quality
           Practices’
    • Abstract: Online-Only Content >>> AdvaMed’s Sharon Segal introduces the device industry group’s new “Library of Successful Quality Practices,” a resource for manufacturers to enhance their own quality processes.
      PubDate: Thu, 16 Oct 2014 12:50:01 -040
       
  • FDA Final Guidance: No Corrections And Removals Reports For Device
           Enhancements
    • Abstract: Online-Only Content >>> CDRH clarifies that Part 806 recall reports are not necessary for actual device enhancements that do not qualify as a correction or removal.
      PubDate: Tue, 14 Oct 2014 19:00:00 -040
       
  • Class III Device Recalls An Afterthought' Not So Fast . . .
    • Abstract: Low-risk class III medical device recalls sometimes fade into the background because they comprise only a sliver of the overall corrections and removals in a given year. Nevertheless, manufacturers should be aware that any decisions they make regarding class III actions are still going to receive FDA attention.
      PubDate: Tue, 14 Oct 2014 15:00:06 -040
       
  • Warning Letter Roundup & Recap
    • Abstract: Zoll cited for QS and MDR violations; FDA instructs maker of drug-of-abuse kits to hire a consultant to audit the firm’s manufacturing and quality assurance systems; Ambco Electronics failed to fully investigate and document device failures. Eight quality-related warning letters were listed by FDA from Sept. 12 through Oct. 14.
      PubDate: Tue, 14 Oct 2014 15:00:05 -040
       
  • Specialized Device Inspectorate Part Of Joint CDRH/ORA Action Plan
    • Abstract: FDA’s Office of Regulatory Affairs will establish a specialized unit of device-focused field investigators according to a 2015 CDRH/ORA program alignment action plan posted online Oct. 7. Under the announced steps, CDRH will work with ORA throughout the current fiscal year to develop a plan for establishing a medical device inspectorate and a separate mammography quality inspectorate.
      PubDate: Tue, 14 Oct 2014 15:00:04 -040
       
  • IMDRF’s Final Software Framework Released
    • Abstract: The International Medical Device Regulators Forum has released a final version of a risk-based framework for software that act as medical devices.
      PubDate: Tue, 14 Oct 2014 15:00:03 -040
       
  • FDA ‘Data Dashboard’ Offers Insight Into Industry Trends
    • Abstract: The new online tool will help assist in analyzing cross-agency inspection, warning letter, enforcement and recall data, the agency says. The dashboard is part of FDA’s ongoing Transparency Initiative.
      PubDate: Tue, 14 Oct 2014 15:00:03 -040
       
  • Odds & Ends
    • Abstract: Specialized device inspectorate part of joint CDRH/ORA action plan A specialized unit of device-focused field investigators will be established according to a CDRH/ORA program alignment action plan posted online Oct. 7. Under the announced steps, CDRH will work with ORA throughout the current 2015 fiscal year to develop a plan for establishing a medical device inspectorate and a separate mammography quality inspectorate.
      PubDate: Tue, 14 Oct 2014 15:00:02 -040
       
  • Recent Warning Letter Close-Outs
    • Abstract: Three quality-related FDA close-out letters were released from Sept. 12 through Oct. 14.
      PubDate: Tue, 14 Oct 2014 15:00:00 -040
       
  • PODCAST: QSIT Team Leader Tim Wells On Using The Inspectional Approach As
           A Learning Tool
    • Abstract: Online-Only Content >>> The coauthor of FDA’s 15-year-old Quality System Inspection Technique, Tim Wells, explains how firms can use QSIT as a learning tool in this “Silver Sheet” podcast.
      PubDate: Tue, 14 Oct 2014 15:00:00 -040
       
  • FDA Releases 2013 Quality System Data; Points Finger At Device History
           Records
    • Abstract: Exclusive Online-Only Content >>> Troubles with device history records are noted as a significant issue in 2013 quality system data released by FDA’s device center. But aside from DHR concerns, there weren’t many other surprises offered by the data.
      PubDate: Mon, 29 Sep 2014 15:50:00 -040
       
  • GUEST COLUMN: Bulletproofing The CAPA Process
    • Abstract: Exclusive Online-Only Content >>> FDA compliance expert John Avellanet takes a look at some of the reasons why corrective and preventive action – CAPA – continues to be a top observation noted in FDA-483 inspection forms and agency warning letters. “An effective, compliant CAPA process produces clear objective evidence easily reviewed by an FDA investigator, ISO auditor or even a product liability litigator,” Avellanet writes.
      PubDate: Fri, 19 Sep 2014 11:45:03 -040
       
 
 
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