(NIST: Gaithersburg, MD) -- Letitia Baldrige, sister of Malcolm Baldrige, died Mon., October 29, 2012, at the age of 86. In announcing her passing, her son Malcolm Hollensteiner told the Foundation for the Malcolm Baldrige National Quality Award, Inc., that “she loved the board and took such pride in what we have done to carry forward Mac’s legacy.”

(FDA: Washington, D.C.) -- In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration (FDA) proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) just concluded its two-day current good manufacturing practices (CGMP) conference, which was co-sponsored by the U.S. Food and Drug Administration (FDA).

(ISPE: Tampa, FL) -- The Food and Drug Administration (FDA) has joined with the International Society for Pharmaceutical Engineering (ISPE) to deliver an integrated learning conference focused on industry and regulatory viewpoints concerning current good manufacturing practices (CGMP). The conference, “Redefining the ‘C’ in CGMP—Creating, Implementing, and Sustaining a Culture of Compliance,” will be held in Baltimore, June 4–5, 2012. It is the first joint ISPE-FDA conference focused on CGMP issues.

(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

(FDA: Silver Spring, MD) -- The Food and Drug Administration (FDA) and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

(FDAnews: Falls Church, VA) -- Is failure mode and effects analysis (FMEA) the cornerstone of your risk management program? Consider this quote from the Food and Drug Administration’s (FDA) quality systems regulation expert Kim Trautman: “Are FMEA or FMECA… good tools? Yes. They are very good tools that can be utilized. Are they in and of themselves a risk management system? Absolutely not. I can’t tell you how many manufacturers I have seen that have tried to present their risk management system by simply presenting a FMEA—that is not a risk management system.

(FDAnews: Falls Church, VA) -- It’s your job to know the FDA’s medical device regulations inside out. But device regulations can be a moving target. Here’s a resource that can help keep them in your sights.

(FDANews: Falls Church, VA) -- FDAnews has announced details of its upcoming CAPA is King Virtual Conference: Tools, Tips, and Techniques for Assuring Compliance, to be held online Dec., 13, 2011, 10 a.m.–4 p.m. EST.

A lot has happened since computer-assisted metrology was invented. In its early stages, computer numerical controlled (CNC) machines were used to control manufactured parts, and it was not until the 1970s that computer-controlled coordinate measuring machines (CMMs) appeared on the market and brought increased precision and acquisition speed.