At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.
Last week, Gawayne Mahboubian-Jones, one of the key thought leaders of the pharmaceutical PAT movement, left a position at Optimal Industrial Automation, whose SynTQ software is finding more users in life sciences, to join Philip Morris International as Program Manager, Excellence in Science and Design.
Rush Limbaugh's and other conservative blogs have been abuzz about a video interview that MSNBC's Dylan Ratigan did with HHS Secretary Kathleen Sebelius yesterday, in which she says that one goal of the healthcare reform bill would reduce drug company profits by almost $90 billion over the life of the bill.
Genzyme is likely to enter into a Consent Decree with FDA over ongoing cGMP problems at its Allston facility. The company says that FDA plans enforcement action. Here, reporting from Wall Street Journal today. Blogger Jim Edwards notes a 14-year history of compliance issues at Genzyme on his blog today.
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.
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,...
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.
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."