Latest Validity Stories

RESEARCH TRIANGLE PARK, North Carolina, January 31, 2013 /PRNewswire/ -- KEMWELL BIOPHARMA PVT LTD, a global pharmaceutical contract development and manufacturing company, announced today that its Oral Solids manufacturing facility located in Bangalore, India has successfully completed a U.S. Food and Drug Administration (USFDA) inspection. The cGMP Audit for a Pre-Approval Inspection (PAI) was triggered by a NDA filing by one of the top ten global pharmaceutical companies....

SALT LAKE CITY, Jan. 29, 2013 /PRNewswire/ -- Nelson Laboratories (www.nelsonlabs.com) will host a free conference session on sterilization validation, packaging, cleaning validations and biocompatibility testing at the 2013 MD&M West Show beginning at 10 a.m. on Feb. 14 in Anaheim, Calif. The sessions outline basic testing and validation requirements medical device manufacturers need to learn to avoid delays when releasing new products. (Logo:...

WOBURN, Mass., Jan. 23, 2013 /PRNewswire/ -- IVT Network, the most trusted resource for validation and compliance professionals in FDA-regulated industries was officially launched today www.ivtnetwork.com. IVT Network provides unmatched regulatory and industry guidance. Members access peer-reviewed journals and archives, training videos, protocols and SOPs, conference compendiums and a variety of other information products. The creator of IVT Network, The Institute of Validation...

CERTON is excited to announce the official launch of their new corporate website. Melbourne, Florida (PRWEB) December 17, 2012 The new design features graphics that will help CERTON broadcast their services in the Aerospace, Medical, and Transportation industries. This custom site makes it easy to find information related to CERTON and the importance of DO-178, DO-254, ARP-4754, and other safety critical product development guidelines in the “no margin for error” safety-critical...

SALT LAKE CITY, Nov. 20, 2012 /PRNewswire/ -- Nelson Laboratories' (www.nelsonlabs.com) cleaning validation expert Alexa Tatarian will present "Cleaning Validations for Newly Manufactured Devices and Single Use Implants" to medical device manufacturers attending the 2012 BIOMEDevice San Jose Conference, Dec. 4-5 in San Jose, Calif. The presentation will take place at the Innovation Briefs Theater in booth #901 on Wednesday, Dec. 5 at 12:00 pm. (Logo:...

MERIDEN, Conn., Oct. 24, 2012 /PRNewswire/ -- Protein Sciences announced that Tim Fields, Vice President of Quality, was named recipient of the Ken Chapman Industry Recognition Award during the International Validation Week Conference presented by the Institute of Validation Technology (IVT) on Oct. 23, 2012. Ken Chapman who died of pancreatic cancer in 2006 was renowned for his forward-thinking approach to regulatory issues and best practices. Many of his ideas have become...

SAN DIEGO, Oct. 9, 2012 /PRNewswire/ -- Bioanalytical and pharmacokinetic specialty Contract Research Organization (CRO) MicroConstants announced today the successful completion of a five-day inspection by the United States Food and Drug Administration (FDA) for compliance with Good Laboratory Practice (GLP) regulations. On September 20, 2012, an investigator from the FDA visited MicroConstants' San Diego facility for a routine inspection to assess the CRO's overall compliance with...

AGAWAM, Mass., Oct. 2, 2012 /PRNewswire/ -- The new scope of cleaning validations for the manufacturers of reusable medical devices is examined in a white paper available for download from http://www.microtestlabs.com/new-scope-cleaning-validation-paper. "Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer...

SALT LAKE CITY, Oct. 2, 2012 /PRNewswire/ -- In light of recent material changes within the medical device packaging industry, Nelson Laboratories is conducting a webinar Oct. 10 at 11:00 am MST for medical device manufacturers entitled, Regulatory Considerations for Managing Changes in Packaging Materials and Test Methods for Validation of Sterile Barrier Materials. (Register for webinar: https://www2.gotomeeting.com/register/360343674) (Logo:...

HOUSTON, Sept. 28, 2012 /PRNewswire/ -- GambleID (http://www.GambleID.com) has moved forward with its application for a Class 2 Service Provider License with the Nevada Gaming Control Board. GambleID, LLC. offers real-time player insight & market intelligence solutions (identity, location, anti-fraud, compliance, & analytics) to the gaming industry. Vendors that supply services to the Gaming Industry in Nevada for Player Identity & Location Validation must be licensed by...