Lachman Consultant Services, Inc. / Articles by: Linda Evans O'Connor
12
May

REMINDER: Lachman Consultants’ Latest Webinar Series Provides Valuable Tips for Responding to FDA Inspectional Observations

By    May 12, 2020    FDA FDA Uncategorized

Whether you’ve been through an FDA inspection before or not, it’s highly recommended that you and your organization prepare for their visit sometime in the not-too-distant future. But despite your best efforts, it’s a very distinct probability that you will receive some inspectional observations. While conduct during an inspection is very important, your behavior post-inspection, […]

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06
May

Lachman Consultants’ Latest Webinar Series Provides Valuable Tips for Responding to FDA Inspectional Observations

By    May 06, 2020    FDA FDA Uncategorized

Whether you’ve been through an FDA inspection before or not, it’s highly recommended that you and your organization prepare for their visit sometime in the not-too-distant future. But despite your best efforts, it’s a very distinct probability that you will receive some inspectional observations. While conduct during an inspection is very important, your behavior post-inspection, […]

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04
May

New Webinar Series From Lachman Consultants Provides Valuable Information To The Pharmaceutical Industry

By    May 04, 2020    News Uncategorized

(Westbury, NY— April 2019) Lachman Consultant Services, Inc. (Lachman Consultants) will be launching a new webinar series beginning with “Preparing for and Handling an FDA Inspection” on Thursday, May 14th at 2:00 pm EDT. Ever a responsive and supportive partner to its clients, these webinars are Lachman Consultants latest effort in providing timely and critical […]

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27
Apr

Lachman Consultants New Webinar Series Provides Timely and Valuable Information To The Pharmaceutical Industry

By    Apr 27, 2020    FDA FDA

Lachman Consultant Services, Inc. (Lachman Consultants) is helping you to navigate the ever-changing economic and business environment with our new webinar series. During these times of social distancing and working remotely from home, these webinars are Lachman Consultants latest way of providing you with up-to-the-minute, valuable information to about a wide range of topics that […]

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27
Apr

FDA Launches Webpage on COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

By    Apr 27, 2020    Biologics COVID-19 FDA Generics Guidance Medical Devices New Drugs

FDA recently launched a comprehensive listing of COVID-19 related guidance documents, which can be found here.  Tracking all COVID 19 related documents can be daunting, as the content is being issued at a fast and furious rate, and this website will make that task a little less onerous. The list is filterable, sortable, and can […]

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27
Apr

Lachman COVID-19 Survey Provides Interesting Insights

By    Apr 27, 2020    Biologics Compliance FDA Medical Devices New Drugs Pharmaceutical industry Science & Technology

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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24
Apr

Impact of COVID-19 on European Inspections

By    Apr 24, 2020    Compliance EU Inspections Regulatory Affairs

The European Commission, the European Medicines Agency (EMA), and national competent authorities have recently issued an updated Question and Answers document on Regulatory Expectations for Medicinal Products for Human use during the COVID-19 Pandemic.  The guidance can be found here. The guidance covers the following topics: Issues related to marketing authorizations, marketing authorizations procedures Manufacturing, […]

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23
Apr

Lachman Consultants COVID-19 Survey Results

By    Apr 23, 2020    COVID-19 Uncategorized

From March 31 through April 14, 2020, Lachman Consultant Services, Inc. (Lachman Consultants) conducted a voluntary survey of professionals working in the pharmaceutical, biotechnology, medical device and other sectors related to the greater life sciences industry. The purpose of the survey was to take a “pulse” of the overall organizational and industry impact of the […]

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13
Apr

Lachman Consultants Offers Support to Help U.S. Distilleries and Breweries Manufacture Hand Sanitizer

By    Apr 13, 2020    News

(Westbury, NY – April 6, 2020) For industries not accustomed to working with the FDA or interpreting FDA regulations and guidance in the manufacture of hand sanitizers, this can be a challenging time. In support of these companies’ efforts to aid in stemming the advance of COVID-19, Lachman Consultant Services, Inc. (“Lachman Consultants”) is reaching […]

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