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Last updated on April 18, 2014 at 21:21 EDT

Latest Validation Stories

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...

2014-04-10 08:29:21

DUBLIN, April 10, 2014 /PRNewswire/ -- Research and Markets (http://www.researchandmarkets.com/research/vsg743/in_vitro) has announced the addition of the "In Vitro Diagnostic Directive (Seminar, London)" [http://www.researchandmarkets.com/research/vsg743/in_vitro ] conference to their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ) The In Vitro Diagnostic Directive Seminar will take place on the 8th & 9th May 2014 at The Rembrandt...

2014-04-02 23:32:53

Cambridge Biomedical Inc. announces that their Chief Operating Officer, Dr. John Reddington, will be attending the 4th annual World Orphan Drug Congress in Washington D.C. April 23-25th, 2014 Boston, MA (PRWEB) April 02, 2014 Cambridge Biomedical’s experience with bioanalytical assay development, optimization, validation and diagnostic testing has proved instrumental in assisting biotechnology and pharmaceutical companies that are focusing on therapies for orphan and ultra-rare disease...

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...

2014-03-27 23:25:01

New and informative webinar will explore the current state of eCOA and the future offered by BYOD, while highlighting some of the issues that need to be addressed to move the industry forward. The broadcast takes place on Thursday, April 17, 2014 at 11:00 EDT (16:00 UK BST/ GMT+1). Toronto, Canada (PRWEB) March 27, 2014 Despite some perceived challenges, electronic data capture has been widely accepted as being superior to paper, and has been adopted by a number of companies as the...

2014-03-26 23:32:15

This report from FDAnews is the ultimate guide to preparing drugmakers for compliance with Good Distribution Practice (GDP). Step by step, it walks readers through the planning and implementation process, including the six key requirements included in the EU’s GDP guidelines. Falls Church, VA (PRWEB) March 26, 2014 Creating a Master Plan for Drug Warehousing, Transportation and Distribution **FDAnews Management Report** http://www.fdanews.com/DrugWarehousingReport Did a truck driver...

2014-03-26 12:33:40

Service Objects' latest product helps to quickly identify fraudulent transactions by authenticating the validity of customer information before the order reaches credit card processing. SANTA BARBARA, Calif., March 26, 2014 /PRNewswire/ -- In today's world of open proxy networks like Tor, stolen credit cards and elaborate hacking schemes; virtual fraudsters have ample ways to steal from online retailers. The impact is felt globally - according to the Association of Certified Fraud Examiners...

2014-03-25 23:27:41

Crest Solutions to Deliver Global Vision’s Proofreading Technologies to Packaging Industries in the UK and Ireland Montreal, Canada and Cork, Ireland (PRWEB) March 25, 2014 Global Vision, the industry leader in the development of innovative proofreading technologies, has signed Crest Solutions as a new reseller in Ireland and the United Kingdom. Under the terms of the agreement, Crest Solutions will resell the complete Global Vision product line and provide valued support for their...

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 23:02:33

Pharmaceutical manufacturers are required by the FDA to train personnel in FDA quality system requirements and procedures. Now manufacturers can train their staff for significantly less money, in their own office, with a new training video developed by a former FDA investigator. Falls Church, VA (PRWEB) March 19, 2014 Quality Systems Training DVD for Drugmakers **FDAnews DVD Training Course** http://www.fdanews.com/QualityDrugDVD Pharmaceutical manufacturers are required by the FDA to...