August: normally full of summer… sun, sand and surf. As the song goes, “summertime and the living is easy…” In 2020, COVID-19 — and more recently its Delta variant — wreaked havoc on an orderly return to business... Read more
I worked for a Chief Quality Officer a number of years ago who always had this response when our company was contemplating movement of a large volume of internal production to third parties: “You can delegate your responsibilities... Read more
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... Read more
Try as I might in my consulting work, I can never seem to get away from CAPA. As much as I would like to help companies prospectively improve their process control; embrace better quality system integration and document... Read more
This is an UPDATE to a post from May 2010. Please click this link for the original post. On Monday, June 21, Apple released the IPhone OS4. This update to the Apple IPhone operating system added great new... Read more
Join the Center for Business Intelligence for a one-hour, information-packed webinar on managing FDA inspections from a more aggressive FDA. Now that pharmaceutical, medical device, dietary supplement, and biologics' companies know that the FDA is back on the... Read more
Aren't the IPhone and the IPad great?? All of the information you could possibly want, right there at your fingertips! As Quality & Compliance professionals, we often need to reference a section or two in the regulations. ... Read more
I’m struggling to find an answer to the following question: If you were the owner of a company, how much would you spend, year over year, to prevent a potential loss in market value to your company of... Read more
