Quality Digest

(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.

(FDAnews: Falls Church, VA) -- FDAnews has announced details of its upcoming 4th Annual Risk Management and Drug Safety Summit: Building an Effective Global Risk Management and Drug Safety Program, scheduled for Nov. 1–2, 2011, in Washington D.C.

(STAT A MATRIX: Edison, NJ) -- Can your organization survive a Food and Drug Administration (FDA) inspection? Are you aware of the different aspects of your business that the FDA will be inspecting? This course, “FDA’s Quality System Inspection Technique (QSIT),” is intended to facilitate manufacturer compliance with the FDA’s Quality System Regulation (QSR) and related regulations, and increase inspection consistency, product quality, and the efficiency of the enforcement action review process.

(IRCA: London) -- The International Register of Certificated Auditors (IRCA) has launched a new Pharmaceutical Quality Management Systems (PQMS) Auditor certification scheme (ICH Q10), to support the assurance of global supply-chain integrity.

In a sector that has seen an increase in the contracting out of operations, and increasingly complex global-supply chains, companies and regulators are asking for evidence of relevant training and experience for pharmaceutical QMS auditors who conduct audits of suppliers, service providers, contractors, and their own operations.

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global, nonprofit association serving more than 22,000 pharmaceutical science and manufacturing professionals, will present a conference focused on good automated manufacturing practices (GAMP). The event, “Improve Productivity with Risk-Based Systems Validation,” will take place in New Brunswick, New Jersey, on Sept. 12–13, 2011, and will be offered again in Brussels, Belgium, on Nov. 14–15, 2011.

The Food Safety Modernization Act (FSMA), signed into law by President Obama in January 2011, has been called “historic” because it puts the focus of the Food and Drug Administration (FDA) on prevention—working to ensure that unsafe foods are not distributed in the first place.

FDA commissioner Margaret A.