We are happy to announce the publication of the third part of our series. This article, co-authored with colleagues Dr. Ko and Dr. Stein covers how to create a sustainable continuous improvement program with an emphasis on QbD. Happy reading. The link is https://www.pharmaceuticalonline.com/doc/how-to-catalyze-sustain-continuous-improvement-in-pharmaceutical-operations-0001
Part 2 of a series of articles about Pharma implementation of new regulations and quality systems is out and available for viewing at a number of sites including Pharmaceuticalonline.com Happy reading.
In a recent article we presented data showing that QbD has been difficult to implement. This new articles teases apart the issues based on public data and interpretation. Enjoy the read. The link is here
This has always been a question people ask. As a consultant i see a slice of the industry that interacts and works with me, so I have my opinions. However, a company that employs me may not represent the average company. So a colleague of mine, Peiyi Ko, and I decided to conduct a survey asking these questions. we used Survey Gizmo as the survey tool and LinkedIn Groups as the interface. These 40 questions were posed and because of the interesting answers we got, we are publishing them in two parts. This post has the first part published in Pharmaceuticalonline. In this part, we examine the implementation of various guidances and regulations. The second will feature how ell they have impacted the company Quality Management System.
The second part will be published in a couple of months. Bookmark my website so you will see it when the next is posted.
Happy reading
I just had an article describing the Compounding industry and what the FDA is doing about it. Here is the link.