CAPA Basics – Carl Anderson and Barbara Immel

I always enjoy running across well-written GXP articles.  Kudos to Carl for posting this informative CAPA Basics article by Barbara Immel on his blog (GXP Perspectives), CAPA Basics- Corrective And Preventative Action.
I’ve been following Barbara Immel’s writing for some time, and always pick up several pearls of wisdom from her.
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Medical education reform on WIHI

Today’s edition of WIHI (2pm-3pm EDT) promises to be timely and informative. The topic is “The Next Wave of Reform for Medical Education.” The guests are Donald M. Berwick, MD, President and CEO, Institute for Healthcare Improvement; Lucian L. Leape, MD, Chair, Lucian Leape Institute at NPSF, and Adjunct Professor [...]

New Blog: Info-Stream

Hungry for new content? Visit Info-Stream. See you there.

My friend Katherine . . .

. . . today learned that she had been accepted by the college of her choice. That she was headed to college before today was already clear, in that she had been admitted by others, but she was anxiously awaiting the news from this particular school.
I’m just a family friend, so when I called [...]

New Blog: Info-Snacks

Hungry for new content? Visit Info-Snacks. See you there.

Biosimilars In Recently Passed Healthcare Bill

I was really surprised to find out that biosimilars are included in the recently passed healthcare bill, Patient Protection and Affordable Care Act.  I learned about this while reading Kevin O’Donnell’s post on his blog (Where cooler heads prevail), “New U.S. Healthcare Bill Includes Pathway for Biosimilars and 12 Year Patent Exclusivity.”
Kevin writes:
“This provision, Title [...]

Berwick –> CMS

The New York Times reports that President Obama will name Don Berwick, CEO of the Institute for Healthcare Improvement, to be head of the Medicare agency, CMS. Don is an extraordinary leader in the quality and safety movement, and his appointment would send a strong signal as to the direction of US health care [...]

New Blog: Healthy Info-Snacks

Hungry for new content? Visit Healthy Info-Snacks. See you there.

FDA Controversy – Regen Biologic’s Menaflex Device

The FDA is reassessing the safety of a device (Regen Biologic’s Menaflex Device) that it previously approved for patients. The FDA conducted a March 23, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting. Although the panel expressed that they would have liked to have seen more data on the device, they largely backed it as a safe and effective [...]

The future of publishing

Worth watching.

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