Submitted by pharmamanufacturing on Mon, 03/08/2010 - 22:07.
This week, the FDA will lose its most eloquent advocate for process analytical technologies (PAT): Ali Afnan, senior staff fellow at CDER's OPS. who leaves the Agency this Friday to pursue a career in independent consulting. A member of the original PAT team led by Ajaz Hussain, Dr. Afnan had pioneered the use of PAT at AstraZeneca in Europe.
Submitted by pharmamanufacturing on Fri, 03/05/2010 - 15:22.
We can all use a bit of humor, and we can use your help in generating some humor on our web site. To keep things light, we've introduced a feature called Funny Pharm, an original cartoon each month that we'd like you to write a caption for.
Submitted by pharmamanufacturing on Wed, 02/24/2010 - 23:27.
I confess that I feel a bit angry that over 60,000 highly trained people in the industry lost their positions last year, during one of the worst recessions in recent history.
Submitted by pharmamanufacturing on Wed, 02/24/2010 - 22:42.
I recently interviewed Michelle Alton, a senior pharma professional who is in the middle of a job search. The market is tough out there, she says, and networking is key.
Submitted by pharmamanufacturing on Thu, 02/18/2010 - 01:41.
From the Wharton business school, an interesting piece on an easy way to motivate employees...connect them to those who benefit from their work. Professor Adam Grant has tested this theory and found it works....I'm betting that plant accidents or quality problems wouldn't happen as frequently if employees had regular contact, of some sort, with the end users of the products they make. For more, read on.
Submitted by pharmamanufacturing on Tue, 02/16/2010 - 20:14.
The compliance consultants, Vectech, are now offering virtual cGMP consulting services, to help drug manufacturers deal with FDA compliance questions immediately via videoconferencing. The company is promoting this as a way to eliminate travel costs, yet ensure "face time." Costs are said to be a fraction of what traditional consulting runs. For more, read on.
Submitted by pharmamanufacturing on Tue, 02/09/2010 - 16:05.
Overall Equipment Effectiveness is a hot topic these days and it's one area that drug manufacturers are achieving clear time and cost savings without too much effort. Setting OEE percentage targets and aiming to achieve world-class production levels can be a truly motivating exercise, as Teva's Duane Hiveley told me recently--see "Leveraging the Simplest KPI" about Hiveley's initial efforts with OEE in Irvine, California.
Submitted by pharmamanufacturing on Fri, 02/05/2010 - 17:54.
FDA has been advocating process knowledge and understanding for a long time now. The Agency's statements always generate "hear, hear's" and motherhood-and-apple-pie type assents and approvals among industry types...."Of course, we need to understand our processes."
But at times I wonder: Is everyone paying attention? Is anyone? Must full-out production always trump product quality and patient safety?
This week, the FDA will lose its most eloquent advocate for process analytical technologies (PAT): Ali Afnan, senior staff fellow at CDER's OPS. who leaves the Agency this Friday to pursue a career in independent consulting. A member of the original PAT team led by Ajaz Hussain, Dr. Afnan had pioneered the use of PAT at AstraZeneca in Europe.
We can all use a bit of humor, and we can use your help in generating some humor on our web site. To keep things light, we've introduced a feature called Funny Pharm, an original cartoon each month that we'd like you to write a caption for.
I confess that I feel a bit angry that over 60,000 highly trained people in the industry lost their positions last year, during one of the worst recessions in recent history. 
I recently interviewed Michelle Alton, a senior pharma professional who is in the middle of a job search. The market is tough out there, she says, and networking is key.
