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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03
Apr

COVID-19 Devices in the Fast Lane – Help is Here!

Lachman Consultants recognizes the urgency of supporting the COVID-19 response efforts.  Companies may be adding additional personnel or expanding manufacturing resources to aid in producing life-saving medical equipment and supplies.  While COVID-19 is requiring non-essential personnel to stay home and stay safe, these teams are at the forefront.  We want to assure you that Lachman […]

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01
Apr

Lachman Reach-Out to New Hand Sanitizer Producers in Support of the COVID-19 Effort

Lachman Consultants is reaching out to U.S. distilleries and fermenters to provide support and guidance for the manufacture of hand sanitizers.  In response to several phone calls from industries wanting to help in the COVID-19 efforts, Lachman is responding with an interpretation of the most recent guidance from the U.S. Food and Drug Administration (here […]

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29
Aug

FDANEWS Webinar: Combination Products: Managing Design Controls

Featured Speaker Ricki Chase, Director, Lachman Consultant Services Inc. Ms. Chase is former Director of the FDA Investigations Branch, where she was responsible for all operations including inspections, investigations, sample collections, consumer complaints, import operations and emergency response programs. Ms. Chase is an expert in implementation of food and drug law, compliance law, and current […]

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15
Jun
The Digital Life Image

The Digital Life

In a recent blog post, FDA Commissioner Scott Gottlieb reinforced FDA’s plans for supporting the growing innovation in medical technology.  Dr. Gottlieb reemphasized the support for digital medical technologies through the implementation of the 21st Century Cures Act, which requires FDA to clearly define those technologies that are used for the promotion of health life […]

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10
Aug
Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients Image

Dietary Supplement Manufacturers, Are You Ready for FDA?

The dietary supplement industry has been burgeoning since the 1990’s when the number of products on the US market was approximately 4,000. In 2015, the journal Drug Testing and Analysis estimated the number of US manufacturers to be approximately 15,000, accounting for more than 90,000 products and a $40-billion-dollar industry.  The Lachman blog has extensively […]

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13
Jul

FDA SUPPORTS SHARING FEEDBACK ON INVESTIGATOR CONDUCT DURING INSPECTIONS

If you work in regulated industry, you will eventually be inspected by the Food and Drug Administration (FDA).  With each inspection comes an opportunity to forge good working relationships with the individuals on the forefront of your compliance status.  With so much riding on any given inspection, what do you do if problems arise with […]

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