Science & Technology

22
May

WHY YOUR QUALITY CULTURE MATTERS NOW MORE THAN EVER

Nothing is normal these days.   We’ve learned to be creative in everything we do during this crisis, from where and how we work, to finding scarce resources in both our work and personal lives.  Rules have changed to accommodate circumstances, and expectations have been colored by those changes.  Take for example FDA’s Emergency Use Authorization […]

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14
May

Lachman OnCall™ GMP Teleconsulting for the Life Sciences

Need answers to your urgent life science questions? Lachman Consultant Services, Inc. (Lachman Consultants) has launched Lachman OnCallTM GMP Teleconsulting. It’s your opportunity to speak to our Subject Matter Experts (SMEs) regarding your questions as they occur. Whether you have questions about compliance or a complex scientific or technical issue, we’re here and ready to […]

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27
Apr

Lachman COVID-19 Survey Provides Interesting Insights

Lachman Consultants recently conducted a survey of professionals working in the pharmaceutical, biotechnology, medical device, and other regulated sectors related to the greater life sciences industry with the goal of taking the “pulse” of the overall organizational and industry impact of the COVID-19 pandemic. The results of the survey can be found here. A few […]

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21
Apr

Sci-Fi to Reality!

Science fiction has always been the white board for technological innovation.  Think of all the books and/or movies you have digested.  How many times have you said, “well, that will never happen?” And looking back, how many futuristic concepts have eventually become reality?  More than you may realize. Let me give you a few fun […]

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17
Apr

Another Histamine H2 Receptor Antagonist Implicated in the NDMA Impurity Saga

The FDA posted a notice indicating that they continue “to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine and is now aware of NDMA in nizatidine, which is chemically similar to ranitidine.“ They have found levels on NDMA in one company’s product that exceed the accepted limits and that company has initiated recall […]

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07
Apr
world map, creative abstract design background photo

How Do Bad Facts Become Fake News and Possibly Worse?

Oftentimes, we hear startling statistics that make us shiver and can cause a knee jerk reaction.  Much has been written about the quantity of drugs that come from overseas, and the push for moving manufacturing of active pharmaceutical ingredients (API) and finished dosage forms (FDF) back into the U.S.  While bringing jobs back to the […]

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07
Apr

In Case You Did Not Know – Lachman Consultants Offers Remote Training Options

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 […]

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02
Apr

Ranitidine Market Withdrawal Mandated by FDA

These days, everybody’s attention is focused is focused on COVID-19.  However, that does not mean that the issues that the FDA was struggling with prior to the pandemic have disappeared.  In fact, some rather major news regarding nitrosamine impurities was announced by the FDA yesterday (and it wasn’t an April Fools’ Day stunt!). Yesterday, the […]

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18
Mar

Mission Critical Only Inspections Starting on March 19

On March 10, 2020 FDA announced it was postponing all foreign inspections and on March 18, 2020, only 8 days later, FDA announced it was also stopping all domestic inspections unless mission critical until such time as it is deemed safe for FDA employees and their families as well as the employees of the firms […]

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