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Validation Times articles

1,920 total articles

Monthly newsletter that publishes FDA inspection reports for cleaning, computers, process, and utilities. Includes news and compliance tips, guidance and regulation tracking, and analysis of FDA warning letters of validation.

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<a href="http://www.accessmylibrary.com/archive/134486-validation-times.html" title="Articles and back issues from Validation Times">Articles and back issues from Validation Times</a>

Validation Times back issues

2009	January 2009 February 2009 March 2009 April 2009 May 2009
2008	January 2008 February 2008 March 2008 April 2008 May 2008 July 2008 August 2008 September 2008 October 2008 November 2008 December 2008
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2003	January 2003 February 2003 March 2003 April 2003 May 2003 June 2003 July 2003 August 2003 September 2003 October 2003 November 2003 December 2003
2002	January 2002 February 2002 March 2002 April 2002 May 2002 June 2002 July 2002 August 2002

More back issues from Validation Times: 1 | 2

Recent articles from Validation Times

Biopharmaceutical firms push harmonized audits to eliminate cost, duplication.(Inspections)
May 1, 2009... ATLANTA -- Biopharmaceutical manufacturers are eager for harmonized audits to avoid duplication of effort and save costs, which for some firms can be as high as $400,000 a day to achieve compliance in the U.S., EU and other nations with differing inspection approaches. Addressing the BIO...

Proposed FY 2010 budget targets medical product and food safety.(FDA)
May 1, 2009... FDA has requested a 19% budget increase for fiscal year 2010 (Oct. 1, 2009 through Sept. 30, 2010), which would yield a $3.2 billion budget aimed primarily at food safety, but also with millions for drug, device and biologic safety and GMP compliance. More than $160 million will fund an...

FDA says knowledge of overseas operations is vital to secure supply chain.(Import Safety)
May 1, 2009... WASHINGTON -- Ensuring a safe supply chain is a complex, ongoing process, and some at FDA feel they're working without a complete set of tools. "As the world has gotten bigger and complexity has increased, we don't have adequate information about supply chains, including participants and...

Cell source, reagents and validation key to FDA; Novocell, Lonza outline their methods.(Stem Cells)
May 1, 2009... ATLANTA -- Manufacturers seeking to market therapeutics from stem cells should focus their efforts on building quality into the product through the consistent control of cell source, reagents, facility, personnel and equipment, and the validation of manufacturing process, aseptic processing,...

Genentech has 2 QbD proposals to CDER as EMEA seeks ways to ease difficulties for biotech drugs.(Quality by Design)
May 1, 2009... ATLANTA -- FDA has accepted two proposals from Genentech for a Center for Drugs pilot to make it easier for biotech products to use Quality by Design for review, and the agency, along with its European counterparts, is trying to ease the path. In June 2008, CDER's Office of Biotechnology...