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Latest Validity Stories

2014-06-10 08:29:23

-Consulting at Every Phase of the Product Life Cycle- SALT LAKE CITY, June 10, 2014 /PRNewswire/ -- Nelson Laboratories (www.nelsonlabs.com) announced today the expansion of its services with the addition of a dedicated Technical Consulting Services group for MedTech companies. Technical Consulting Services encompasses product development, facility and process validation, product performance testing, and regulatory support to help clients deliver medical devices to market that are safe and...

2014-06-09 23:08:44

Zentech Manufacturing Inc., is an electronics manufacturing services (EMS) company located in Baltimore, Maryland and underwent an intensive two-day audit based on two of IPC’s foremost standards: IPC J-STD-001, Requirements for Soldered Electrical and Electronic Assemblies and IPC-A-610, Acceptability of Electronic Assemblies. Unlike the ISO-9001, ISO-13485 and AS-9100 certifications which only certify a company's Quality Management Systems, the IPC QML process is the only...

2014-06-03 12:20:52

BRENTWOOD, Tenn., June 3, 2014 /PRNewswire/ -- OHL, a leading global 3PL provider, announced today that it has met all Food and Drug Administration (FDA) validation requirements for its primary warehouse management system (WMS) Synapse. http://photos.prnewswire.com/prnvar/20110708/CL31865LOGO "The validation of our WMS shows we are committed to meeting the quality and regulatory requirements that come with healthcare," said Shawn MacCartey, OHL Senior Vice President, Healthcare....

2014-05-27 16:20:35

ALLEN PARK, Mich., May 27, 2014 /PRNewswire/ -- David Ploucha, President of vehicle data acquisition and analysis software company Control-Tec, will address the Chevrolet Detroit Belle Isle Grand Prix 2014 Technology Forum on Wednesday, May 28(th). He will be speaking - from the vantage point of a successful start-up - about market opportunities related to the "Big Data" potential emanating from vehicle systems development and testing. "Control-Tec's OEM clients are amassing vast...

2014-05-15 23:03:22

The FDA is cracking down on companies that don't carry out device software verification and validation, issuing an increasing number of 483s and warning letters to manufacturers of medical devices with embedded software, and manufacturers of software used as a device itself. With this new report, readers will find out exactly what FDA inspectors are being trained to look for in terms of device software verification and validation. Falls Church, VA (PRWEB) May 15, 2014 Implementing an...

2014-05-12 23:11:46

If drugmakers haven’t started revalidating processes and using change control SOPs, they’re headed for 483s and recalls that could cost millions of dollars. In a 90-minute webinar process validation expert Rich Yeaton shares his road-tested “roadmap,” a template that will enable drugmakers to use existing PV data to satisfy regulators. Falls Church, VA (PRWEB) May 12, 2014 Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny **FDAnews Webinar**...

2014-05-05 23:03:35

May 7-9th - Avomeen Analytical Services will join others in sponsoring the 2014 Extractables and Leachables USA Conference in Silver Spring, MD. (PRWEB) May 05, 2014 From May 7-9th the Extractables and Leachables USA Conference will host over 18 renowned speakers in the areas of pharmaceutical packaging and medical device safety. The independent testing laboratory, Avomeen, will be among the exhibitors at this conference providing their knowledge in the areas of complex E&L analysis,...

2014-05-02 23:03:36

To examine recent reports of published results that cannot be independently reproduced, the Cancer Biology Reproducibility Project will independently replicate 50 recent high impact cancer biology studies. BioLegend will support this initiative by donating $100,000 of research reagents. (PRWEB) May 02, 2014 The ability to reproduce published results is key for scientific progress. However, recent studies have reported that many published results cannot be independently reproduced. To...

2014-04-28 08:33:20

FREMONT, Calif., April 28, 2014 /PRNewswire/ -- ValGenesis, Inc., the Global market leader in Validation Lifecycle Management Solutions (VLMS), announced today it has released multi organization functionality along with multilingual support for global life science companies. The latest version of ValGenesis VLMS is the most enhanced, integrated and proven validation lifecycle management platforms adopted by global life science companies. Already featuring the highest level of...

2014-04-16 23:17:29

Device manufacturers understand that they must answer the two key design verification and validation questions: did they make the product right and did they make the right product? Learn proven tactics and tools to develop a strong statistical methods program — and a thorough understanding of what FDA auditors look for when they come for an inspection. Falls Church, VA (PRWEB) April 16, 2014 Sample Size Considerations for Verification and Validation: Tools to Safely Speed Your Device to...


Word of the Day
bibliopole
  • A bookseller; now, especially, a dealer in rare and curious books.
This word comes from a Greek phrase meaning 'book seller.'
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