(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?

(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.

(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 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 f

(Compliance2go: Houston) -- More organizations are striving to “go green” and develop sustainable strategies, many of which involve using computer- and cloud-based technologies.

(FDA: Silver Spring, MD) -- The FDA has announced that it will open a public docket to begin receiving public comments on the Institute of Medicine’s (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices.

(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

(FDA: Silver Spring, MD) -- The U.S.

(FDAnews: Falls Church, VA) -- Despite the FDA’s ongoing work with international regulators to improve supplier quality issues, a top FDA official has stated that another public health crisis like Heparin, which occurred in 2010 when Baxter Healthca