Quantcast

Latest Validity Stories

2014-01-27 08:28:19

Event focus is risk-based approaches for FDA-regulated complex systems BOSTON, Jan. 27, 2014 /PRNewswire/ -- IVT Network (www.ivtnetwork.com), the global leader in validation training for FDA-regulated industries, announced today the agenda and speaking faculty for its 15(th) Annual Computer and Software Validation Conference. The large annual flagship conference is being held April 23-25, 2014 at the Hyatt La Jolla in San Diego, CA. Designed for managers, directors and vice presidents in the...

2014-01-15 23:28:11

The Device Software Verification and Validation 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) January 15, 2014 Device Software Verification and Validation: Get Ready for a New Breed of Investigators **FDAnews...

2014-01-14 23:28:15

Medical Software Expert to Speak on Software Design, Validation and Agile Methodologies Dedham, MA, USA (PRWEB) January 14, 2014 ShoeBar Associates (http://www.shoebarassoc.com/) will play a major role in the 4th Software Design for Medical Devices conference in Europe, 27-30 January 2014, in Munich Germany (http://www.sdmdeurope.com). Brian Shoemaker Ph.D., Principal Consultant, will reprise his workshop "What is Validation? Covering the Basics and Beyond," previously featured...

2014-01-07 08:31:40

MILLBURY, Mass., Jan. 7, 2014 /PRNewswire/ -- BellHawk Systems www.BellHawk.com today announced the availability of a 21 CFR Part 11 compliance module. This enables the use of the BellHawk inventory and work-in process tracking software in FDA regulated pharmaceutical manufacturing and distribution applications that need to be validated to comply with FDA good manufacturing practices (GMP). (Logo: http://photos.prnewswire.com/prnh/20140107/PH41520LOGO ) A major issue for small- to...

2013-12-19 23:27:31

When FDA-regulated companies fail to do the basics of Verification and Validation, warning letters and Forms 483 often follow. Shifting to risk-based V&V helps keep them on the FDA’s good side. Falls Church, VA (PRWEB) December 19, 2013 Implementing Risk-Based Verification and Validation **FDAnews Management Report** http://www.fdanews.com/RiskBased Switching to risk-based verification and validation is likely to save drug and devicemakers money on projects, plus reduce liability...

2013-12-16 23:22:27

For drugmakers, complying with FDA current GMP requirements is mandatory, but since the regulations were all drafted and implemented at different times over decades, the collection of documents that implement today’s GMP requirements have been widely scattered. Until now. Falls Church (PRWEB) December 16, 2013 Guide to FDA Pharma GMP Regulations — 2014 **FDAnews Publication ** http://www.fdanews.com/PharmaGMP The Guide to FDA Pharma GMP Regulations — 2014 is a compilation of...

2013-11-30 23:20:28

Antimicrobial Test Laboratories (ATL) – an FDA GLP compliant microbiology lab founded in 2006 by microbiologist Dr. Benjamin Tanner – now offers robust services for validating disinfection in pharmaceutical manufacturing environments. Round Rock, TX (PRWEB) November 30, 2013 Antimicrobial Test Laboratories (ATL) – an FDA GLP compliant microbiology lab founded in 2006 by microbiologist Dr. Benjamin Tanner – now offers robust services for validating disinfection in pharmaceutical...

2013-11-20 23:30:02

On June 6th, in a conference room in Bethesda, MD, two former high-ranking FDA veterans, Martin Browning and Janis Olson led a one-of-a-kind strategy session on how to create a bulletproof medical device supplier quality system. Falls Church, VA (PRWEB) November 20, 2013 For the attendees in the room, getting first-hand insight from their 44 years of experience was a goldmine. Now devicemakers can have that goldmine too. Announcing — The Insider’s Guide to Supplier Quality Success:...


Word of the Day
glogg
  • Scandinavian punch made of claret and aquavit with spices and raisins and orange peel and sugar.
This word comes from the Swedish 'glogg,' which is an alteration of 'glodgat,' mulled (wine).
Related