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Latest Validity Stories

2014-08-20 23:13:03

Kirby Lester's KL1 tablet counter for pharma manufacturing QC reduced quality control (QC) time by 50% and increased counting accuracy for an international contract pharmaceutical packager. Lake Forest, IL (PRWEB) August 20, 2014 Kirby Lester, LLC, a leading counting technology provider, announced its best-selling KL1 tablet counter reduced quality control (QC) time by 50% and increased counting accuracy for an international contract pharmaceutical packager. The KL1 was the subject of...

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...

2014-08-14 23:11:14

With 15 interactive exercises, this workshop, taught by internationally renowned medical device process validation expert Dan O’Leary, is designed to provide industry best practices to achieve sustainable process validation with regulatory bodies around the world. Attendees will learn the theories of process validation and documentation and how to put them into practice. Falls Church, VA (PRWEB) August 14, 2014 Innovative Process Validation Strategies for Medical Devices: Proving Your...

2014-08-01 23:06:14

Cambridge Biomedical Inc announces contract with a major biopharmaceutical company for a GCLP Bioanalytical Assays and Sample Testing project extending into 2015. Boston, MA (PRWEB) August 01, 2014 Cambridge Biomedical Inc announces contract with a major biopharmaceutical company for a GCLP Bioanalytical Assays and Sample Testing project extending into 2015. Cambridge Biomedical’s experience in bioanalytical assay development, optimization, validation and diagnostic testing coupled...

2014-07-31 23:18:36

The large number of FDA warning letters continually issued for improper equipment qualification is a clear sign that companies are still struggling to correctly implement this USP 1058 general chapter. During this webinar, Dr. Ludwig Huber, PhD will take attendees step-by-step through the complete qualification process and teach them how to create a bullet-proof master plan that will pass FDA scrutiny. Falls Church, VA (PRWEB) July 31, 2014 How to Implement USP 1058 for Lab Equipment...

2014-07-30 23:14:44

The FDA has refined its understanding and validation for product, software and processes used for medical production. Protomatic demonstrates its method for adopting the four protocol: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Dexter, MI (PRWEB) July 30, 2014 The methods used to create a stable manufacturing process are based on multiple industrial requirements. When used for medical production, the...

2014-07-28 20:25:54

BOSTON, July 28, 2014 /PRNewswire/ -- Hays Companies of Boston is pleased to announce Melissa Tobler is one of four individuals to date to receive the Validation Institute's Advanced Certification on Critical Outcomes Report Analysis. Intel-GE Care Innovations(TM) launched the Validation Institute to "challenge the status quo of typical healthcare research design principles, with the goal of positively impacting how the industry establishes credibility over time, but also ultimately...

2014-07-24 08:35:27

BETHESDA, Md., July 24, 2014 /PRNewswire-USNewswire/ -- The Parenteral Drug Association (PDA) announced today that 31 of its Training and Research Institute (TRI) courses are now listed with the U.S. General Services Administration (GSA) under a Federal Supply Schedule contract. http://photos.prnewswire.com/prnvar/20130226/DC66667LOGO The 31 courses will be included on the GSA Advantage, GSA's online shopping and ordering system https://www.gsaadvantage.gov/advantage/main/start_page.do)....

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...


Word of the Day
barratry
  • The offense of persistently instigating lawsuits, typically groundless ones.
  • An unlawful breach of duty on the part of a ship's master or crew resulting in injury to the ship's owner.
  • Sale or purchase of positions in church or state.
This word ultimately comes from the Old French word 'barater,' to cheat.
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