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From 'Anita's Test blog'

Testing Teaser Length


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From 'Poor Emil's Almanac'

Read count


I'm testing the changed code for read count.

From 'On Pharma'

testing read count


Testing read counter

From 'Poor Emil's Almanac'

TEsting the Read Count


jsut some text.

From 'Poor Emil's Almanac'

Russ Somma on QbD - "How DId You Launch Before, WIth a Catapult?"


The Competing Globally track also featured a presentation on Quality by Design, made by Russ Somma, President, SommaTech LLC, who worked for several years at Novartis and is also an editorial advisor on PharmaQbD.com.  Mr. Somma joked that the industry never had quality by accident, "We don't just lumber along and wait to fall apart, but the question is: Did you ask the right questions at the right time?" There's a need to better define process needs and required capacity early on.

From 'On Pharma'

Competing in a Global Marketplace: Reports from Julian WIlkins and John Fielding


On Monday afternoon, a manufacturing and operations discussion group focused on the topic of global competition.  Session chair Julian Wilkins, Vice President of PharmaConsult US, Inc. and a part-time professor of Pharmaceutical Manufacturing at Stevens Institute set the stage with an introduction spelling out the issues and challenges.

From 'On Pharma'

Why Can't ISPE Join Up With ASQ? Did You Know About ASQ's Certified Pharmaceutical GMP Professional Program?


A number of speakers at ISPE's conference referred to the Certified Pharmaceutical Industry Professional (CPIP) program that the organization has rolled out, providing certification that an industry professional has met a certain agreed-upon level of competence in GMPs and other critical subject areas.

From 'On Pharma'

"Heparin Was an Industry Wake-Up Call": A Star Turn by CDER's Janet Woodcock


Janet Woodcock, head of FDA’s CDER, strikes me as the type of person you’d want in charge during a crisis.  And that’s exactly where FDA, and CDER, have found themselves this year, so I’m not surprised that Dr. W. was reassigned from her post of Chief Medical Officer and Deputy Commissioner to head up CDER.  Using the triage imagery of the Emergency Room, running the Critical Path initiative is important, but maintaining control of CDER, drug review and inspections, is urgent.

From 'On Pharma'

Notes from ISPE 2008: Hans Rosling on Ending Pharma Parochialism


End Pharma Parochialism: Think Globally, Act Globally

Anyone who still thinks of the term “third world” or uses “industrialized” vs. “developing” to describe world economies was duly chastised, in a most amusing and good-natured way, by Dr. Hans Rosling, Professor of International Health at the Karolinska Institute in Stockholm, Sweden.  (For a video of Dr. Rosling giving a similarly spirited presentation at an event two years ago, click here). 
Dr. Rosling, who cofounded Physicians Without Borders in Sweden, has worked around the world.  While in Mozambique, he discovered “konzo,” a paralytic disease caused by hunger/malnutrition (and badly processed cassava root). With family members, Dr. Rosling also established the Gapminder Foundation in Sweden three years ago, to continue development of Trendalyzer software, which brings statistical information to vivid life.  Google acquired the software last year, but the software can be seen (and played with) via http://www.gapminder.org/.  Its use should be required for anyone giving a presentation that involves statistics and trends.

From 'On Pharma'