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Latest Validation 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...

2014-08-20 23:01:14

Microscan’s upcoming Lunch & Learn event will review FDA UDI requirements and introduce methods for ensuring quality barcodes, labels, and marks that meet the demands of the FDA and the expectations of consumers. Renton, WA (PRWEB) August 20, 2014 Microscan, a global technology leader in barcode, machine vision, and lighting solutions, announces that it will host a half-day educational training event titled “Ensuring the Best Codes for FDA UDI Compliance” – presented by...

2014-08-19 08:30:21

ST. LOUIS, Aug. 19, 2014 /PRNewswire/ -- Sequence, Inc., an industry leader in the field of quality and compliance solutions for pharmaceutical, biotech and medical device manufacturers is opening a third office location in the "Gateway to the West," St. Louis, as a result of demand by clients to provide cost effective solutions to industry. The new location, which opened this month, allows Sequence to better serve new and existing customers in the Midwest....

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...

2014-08-12 08:21:40

PLYMOUTH, Mich., Aug. 12, 2014 /PRNewswire/ -- Johnson Controls' new state-of-the-art crash test facility is now open at its Automotive Seating headquarters in Plymouth, Mich. The 6,000-square-foot facility houses a Seattle Safety ServoSled that allows the automotive supplier to offer the most accurate, standardized safety testing of seats globally through collaboration with its other testing facilities located in Burscheid, Germany; Changchun and Shanghai, China; and Yokohama,...

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...


Word of the Day
endocarp
  • The hard inner (usually woody) layer of the pericarp of some fruits (as peaches or plums or cherries or olives) that contains the seed.
This word comes from the Greek 'endon,' in, within, plus the Greek 'kardia,' heart.
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