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PQ Systems Assumes New Ownership
Company headquarters and 30 jobs in Dayton, operations in Europe, stay in place
New Guidance From FDA Helps Manufacturers Develop Biosimilars
Four guidelines for industry offer useful tools for manufacturers
FDA Works to Clarify Device Data Collection Priorities
Some post-approval studies can replace premarket studies
Quality Digest Now Available on Mobile Devices
Same great content in mobile-friendly format
LNS Research Launches Environment, Health & Safety Research Library
Access research-based best practices, benchmark data, and thought leadership publications
Noted Quality Management Authority Michael J. Cleary Dies at Age 75
Authority on quality management and charter member of Education Division of ASQ
Secretary Pritzker Announces Winners of the 2013 Baldrige National Quality Award
One school district and two healthcare organizations honored
ASQ Seeks New CEO
Must like long gemba walks on the beach
Government Down. Baldrige Up!
Federal funding problem shuts down Baldrige web site, but Baldrige is still alive
Hexagon Metrology Unveils eLearning Portal HexagonMetrologyU
Hexagon moves metrology education beyond the classroom
Letitia Baldrige, Sister of Malcolm Baldrige, Dead at 86
She was instrumental in helping create the Baldrige Performance Excellence Program named after her brother
FDA Proposes Unique Device Identification System for Medical Devices
UDI system could improve quality of information in medical device adverse-events reports
ISPE and FDA Discussed Strengthening Safety at Joint CGMP Conference
Conference addressed how tools are being applied to mitigating risks and manage global supply chains
Current Good Manufacturing Practices Conference
Co-sponsored by ISPE and FDA, June 4–5, 2012, in Baltimore
FDA Issues Draft Guidance on Biosimilar Product Development
Public comment sought on three documents
FDA and Industry Reach Agreement in Principle on Medical Device User Fees
The $595 million collected will will help reduce average total review times, says FDA
Two Days of ISO 14971 Training
March 28–29, 2012, in Boston
2011 Guide to Medical Device Regulations Released
Includes full texts of every device-related regulation currently in force
‘CAPA Is King’ Virtual Conference
Dec. 13, 2011, from 10 a.m.–4 p.m. EST
Optical Reflectors: The Alternative to Rigid Measurement Setups
Reduce errors from unstable environments, increase repeatability and reproducibility

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