Have you assessed the strategic risk of your company’s readiness to meet the following regulation in the future? “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions (21 CFR 211.25(a))” Or […]
In the pharmaceutical industry, some of the most important regulatory expectations are not always found in the main body of a guidance document. Occasionally, a seemingly modest footnote carries significant implications for the future of compliance. One such example appears in the MHRA GxP Data Integrity Guidance and Definitions (March 2018), which states: “It is […]
Training of employees remains a hallmark of the industry’s ability to deliver high quality medicines, devices, and diagnostics. Training is a crucial activity, now, more than ever, in this rapidly changing environment. During this period of social distancing, when the experts cannot travel to your site to perform training, that does not mean that this […]
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 […]
[vc_row][vc_column][vc_column_text css=”.vc_custom_1563454804998{padding-bottom: 25px !important;}”]Three Key Representatives from Lachman Consultants will be traveling to India on July 30 – August 1 for the 5th Annual Data Integrity, Reliability, and Quality Metrics Workshop. This 3-day interactive training event features experts from Lachman Consultants, Frances Zipp, President & CEO, Linda Evans O’Connor, Head of Business Processes and Regulatory, […]
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 […]
I can’t believe another year has slipped away already. Seems like yesterday I was writing the holiday blog for 2015 and here we are again. This year brought us the renegotiations of all of the UFAs, the largest number of Generic Drug approval since the new counting system went into effect (for those of you […]
Whether you are into tofurkey, real turkey, ham or whatever floats your boat, all of us at Lachman Consultants want to take a moment to wish you and yours a happy Thanksgiving. At this time of year, we all need to take stock (no pun intended) of our family and friends and realize that, while […]
On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.
On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.
