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The Silver Sheet  
   [3 followers]  Follow    
   Full-text available via subscription Subscription journal
   ISSN (Print) 1068-5324
   Published by Informa plc Homepage  [13 journals]
  • PODCAST: 5 Things Every QA/RA Professional Should Keep An Eye On In 2015
    • Abstract: Online-Only Content >>> In this "Silver Sheet" podcast, quality/regulatory expert Christine Santagate reads the tea leaves on five hot industry topics that will unfold over the year.
      PubDate: Wed, 21 Jan 2015 16:00:00 -050
       
  • CDRH Compliance Director Steven Silverman Departing
    • Abstract: Online-Only Content >>> Steven Silverman is leaving FDA to pursue other opportunities outside of government. "I’ve never had a better job than my current one. Even so, I feel that it’s time for me to gain experience in other areas," said Silverman, who has not signaled what his next move will be.
      PubDate: Wed, 14 Jan 2015 17:45:01 -050
       
  • Performance Standards Aim To Deliver FDA Guidance Docs To Industry Faster
    • Abstract: Time-based performance standards have been established by CDRH to help ensure that draft guidance documents do not remain in an unresolved state for forever and a day.
      PubDate: Wed, 14 Jan 2015 14:10:01 -050
       
  • Recent Warning Letter Close-Outs
    • Abstract: Three quality-related FDA close-out letters were released from Dec. 18 through Jan. 14.
      PubDate: Wed, 14 Jan 2015 14:00:19 -050
       
  • Warning Letter Roundup & Recap
    • Abstract: Karl Storz didn't have design validation data to show that a brush specified in the instruction manual for its Flex-X2 ureteroscope was appropriate for cleaning the device; QS and MDR reg violations identified at maker of coronary bypass cannulas. Six quality-related warning letters were listed by FDA from Dec. 18 through Jan. 14.
      PubDate: Wed, 14 Jan 2015 14:00:14 -050
       
  • 2014 Hot Spots: Top 4 Device Quality & Regulatory Topics
    • Abstract: Big changes are afoot for inspections, and device stakeholders kept a sharp eye on those issues in 2014, according to "Silver Sheet" readership data. From a CDRH/ORA plan to create a specialized unit of device-focused field investigators, to IMDRF's mostly untested internationally harmonized single-audit approach, readers (and podcast listeners) couldn't get enough news and tips about inspection activities.
      PubDate: Wed, 14 Jan 2015 14:00:03 -050
       
  • Hospira Infusion Pump Ban Lifted By FDA
    • Abstract: FDA lifts two-year import alert that prevented the manufacturer from selling infusion pumps made at its Costa Rica manufacturing facility, including the Plum A+ and LifeCare PCA.
      PubDate: Wed, 14 Jan 2015 14:00:02 -050
       
  • IMDRF Wants User Feedback For Medical Device Single Audit Program
    • Abstract: Device firms that undergo an MDSAP inspection through May will be invited by IMDRF to help with midcourse adjustments to the single-audit pilot program.
      PubDate: Wed, 14 Jan 2015 14:00:01 -050
       
  • CDRH Reviewing, Assessing Guidance Documents From 1985, 1995, 2005
    • Abstract: A plan for systematically reassessing whether established guidance documents need to be revised or withdrawn is unveiled by FDA's device center. CDRH also wants input from the public to identify outdated docs.
      PubDate: Wed, 14 Jan 2015 14:00:01 -050
       
  • Better Standardize Unique Device IDs, Providers Tell Feds
    • Abstract: Panelists at a recent conference argued the three Unique Device Identification issuing agencies and various automated data capture technologies are making adoption of the system by the health care provider community difficult.
      PubDate: Wed, 17 Dec 2014 15:21:00 -050
       
  • ‘An Invisible Profession’: Scarcity Of Quality/Regulatory
           Experts A Call To Action For Educators
    • Abstract: Online-Only Content >>> As baby boomers retire, device manufacturers are scrambling to fill quality and regulatory positions – particularly those in leadership roles, according to an industry survey. Yet many firms are discovering that a number of younger employees – those who typically fill gaps left by retiring managers – have not cultivated the necessary quality and regulatory skills demanded by today's complex global market. "A person going into QA/RA now is not going to be only an expert on United States requirements.
      PubDate: Wed, 17 Dec 2014 15:10:00 -050
       
  • National Joint-Replacement Registry Data Findings
    • Abstract: A new report shows the mean age of knee replacement patients is slightly younger than that of hip replacement patients, and that more females than males are likely to receive joint replacements.
      PubDate: Wed, 17 Dec 2014 15:00:27 -050
       
  • Manufacturers Should Avoid ‘No Latex’ Claim, FDA Says
    • Abstract: Device manufacturers should avoid making claims that products are “latex-free,” “does not contain rubber latex,” or “does not contain latex,” a new FDA guidance says.
      PubDate: Wed, 17 Dec 2014 15:00:23 -050
       
  • Years Of Infusion Pump Screw-Ups Leads To Final FDA Guidance
    • Abstract: Years in the making, the agency’s new guidance is in response to a growing number of reported adverse events linked to the use of infusion pumps. The pumps were the top recalled category of medical devices in fiscal years 2012 and 2013, FDA told “The Silver Sheet” earlier this year.
      PubDate: Wed, 17 Dec 2014 15:00:16 -050
       
  • Surgical-Set Ortho Implants Granted UDI Delay
    • Abstract: Makers of implantable orthopedic devices used as part of customized surgical sets will have an extra year to comply with Unique Device Identification labeling requirements.
      PubDate: Wed, 17 Dec 2014 15:00:12 -050
       
  • Warning Letter Roundup & Recap
    • Abstract: US Infusion didn’t report complaints of leaking IV sets to FDA as Medical Device Reports; quality system deficiencies noted at two Navilyst Medical facilities; maker of patient treatment chairs failed to notify FDA after initiating a product recall. Eight quality-related warning letters were listed by FDA from Nov. 12 through Dec. 17.
      PubDate: Wed, 17 Dec 2014 15:00:04 -050
       
  • PODCAST: 12 Things You Should Never Say To FDA During An Inspection
    • Abstract: Online-Only Content >>> Former longtime CDRH official Cap Uldriks skips over the five golden rings and eight maids-a-milking, and instead reveals 12 things that should never be said to FDA during an inspection in this “Silver Sheet” podcast.
      PubDate: Wed, 17 Dec 2014 15:00:00 -050
       
  • Recent Warning Letter Close-Outs
    • Abstract: Six quality-related FDA close-out letters were released from Nov. 12 through Dec. 17.
      PubDate: Wed, 17 Dec 2014 15:00:00 -050
       
  • 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
       
 
 
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