Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
While attending the 2019 ISPE Annual Meeting in Las Vegas we asked our booth visitors to answer two questions that help gauge the industry in a top-of-mind way. We asked for insight into what is currently on their mind as an organization, and what their biggest takeaways from the event are. This year, it was […]
On June 20, 2019, LCS’ President and CEO Fran Zipp, moderated a panel at the CPhI China exhibition in Shanghai, organized by Informa Markets. The panel discussion, “How Can International and Domestic Manufacturers Collaborate to Improve Quality?” included members from a number of different segments of the regulated industry. Members on the panel were: Aurelio […]
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]
Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here). The document was revised “based on comments made to the draft as well as requests for FDA thinking on current best practices and additional examples.” The guidance does have […]
It is understandable that during an investigation the initial focus is determining the cause along with the associated impact assessment and the identification and implementation of a corrective action. However, what can get overlooked during the investigation process is the importance of trending. This is a key component of root cause confirmation, assessing the appropriateness […]
The Pink Sheet recently posted an article authored by James Davison, Ph.D. Vice President of Lachman Consultants that addresses the criticality of Data Integrity outside of the laboratory. The article highlights that regulators are making clear that issues of data integrity go well beyond what happens in drug laboratories or clinical trials and that the […]
