Responding to Consumer Complaints While Working with CMOs

Ricki Chase, M.S., Vice President, Lachman Consultant Services, Inc. (Lachman Consultants) and Carrie Colella, Senior Director, Lachman Consultant Services, Inc. (Lachman Consultants) take an in-depth look at the questions and challenges manufacturers face and how to respond to consumer product complaints while working with a contract manufacturing organization (CMO). The product, in this case, may […]

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QSR – ISO Harmonization – All Things Being Equal…They Are Not – A Deeper Dive

The US Food and Drug Administration published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on February 23, 2022.  After four years in the works and much debate about what the PR would include, we can finally read it for ourselves.  The question in my mind was […]

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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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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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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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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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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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