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Latest Verification and validation Stories

2014-08-18 23:01:11

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) August 18, 2014 Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed...

2014-07-15 23:01:36

The Device Software Verification and Validation On-Demand Webinar will give attendees a clear understanding of FDA inspector expectations and how to meet them, with a specific focus on software that is as-product, in-product, process and/or in overall manufacturing and operations. Why risk FDA sanctions, let alone multimillion-dollar liability lawsuits? Falls Church, VA (PRWEB) July 15, 2014 Device Software Verification and Validation: Get Ready for a New Breed of Investigators...

2014-07-15 08:37:03

Technologically-advanced service provides online businesses directed towards children under 13 years of age with an easy and reliable solution for complying with COPPA regulations. WESTPORT, Conn., July 15, 2014 /PRNewswire/ -- Imperium, an established industry leader in fraud prevention and identity validation solutions, announced today that it has been granted patent number 8,782,264 by the United States Patent and Trademark Office covering technology in the company's...

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...

2014-05-15 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...

2014-05-08 23:07:29

Enters commercial real estate, borrower’s certification markets with two new services. Beaverton, OR (PRWEB) May 08, 2014 Quiktrak, a global leader in asset verification and inventory audit solutions, today announced that it has added two new inspection services to its portfolio. Quiktrak will now offer Commercial Real Estate Inspections and Borrower’s Certification Inspections to customers in the leasing and finance industry. Quiktrak’s Commercial Real Estate Inspection service...

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...

2014-03-28 23:24:53

The Device Software Verification and Validation webinar rebroadcast will give attendees a clear understanding of FDA inspector expectations and how to meet them, with a specific focus on software that is as-product, in-product, process and/or in overall manufacturing and operations. Why risk FDA sanctions, let alone multimillion-dollar liability lawsuits? Falls Church, VA (PRWEB) March 28, 2014 Device Software Verification and Validation: Get Ready for a New Breed of Investigators...

2014-03-20 23:33:26

Developed by a specialist in pharmaceutical compliance and validation, this FDAnews Spreadsheet Validation training kit will show drug and device manufacturers how to create a spreadsheet validation program that satisfies both business and regulatory requirements. Plus, they will learn basic concepts like determining what the FDA expects from a validation program and how to build validation into an existing QA operation. Falls Church, VA (PRWEB) March 20, 2014 The FDAnews Spreadsheet...

2014-03-19 08:22:20

ALDERLEY EDGE, England, March 19, 2014 /PRNewswire/ -- Gentronix Limited, the leading specialist genotoxicity company, has announced its strategic intention to offer regulatory genotox assays, and is currently working towards 'Good Laboratory Practice' (GLP) compliance. GLP is a quality system of management controls for research laboratories to ensure the quality and reliability of test data from non-clinical safety studies. Specifically, these are studies to examine...


Word of the Day
cenobite
  • One of a religious order living in a convent or in community; a monk: opposed to anchoret or hermit (one who lives in solitude).
  • A social bee.
This word comes from the Latin 'coenobium,' convent, which comes from the Greek 'koinobios,' living in community.
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