September 18, 2014
The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning FDA’s July 2014 Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. As I read this article, the first thing that popped into my […]
October 11, 2013
Although Corporate America has embraced the concept of metrics and dashboards for close to 20 years now, the US Food and Drug Administration (FDA) has only recently come to the conclusion that incorporating a review of company-provided product quality metrics into its inspection and enforcement prioritization model will provide the Agency with an increased understanding of product […]
October 2, 2013
I had an interesting phone call today with a company named ZenDoc, a software company, headquartered in Dublin, Ireland. The company contacted me to introduce me to their “new” document management software that in their words, is “new and different” from what is currently being offered for FDA-regulated companies. Although I was busy, some of […]
January 31, 2012
If you have any role within an FDA-regulated company, it is likely you are aware that the FDA has been much more focused on FDA warning letters enforcement activities since 2008. Alternatively, if you are involved at all with supply chain, manufacturing, quality assurance, quality control, regulatory affairs or other FDA compliance activities, you are […]
June 28, 2011
The new FDA Inspections Database is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement actions and results across the country and rest of world. Analyzing Regional Trends It is certain that the information will be of value to those parties that are interested in […]
July 20, 2010
A couple of months ago I was engaged in a brief, friendly dialogue with one of my close friends – a college buddy – about a current business imperative: urgency. My friend is a Senior Partner with a large, very well-known business consulting firm, and has responsibility for major projects within large FDA-regulated companies. “Urgency” Book […]
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