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14
Sep

Lachman OnCall™ GMP Teleconsulting – When you can’t wait to get going.

When you can’t wait for answers to your GMP questions, it’s time for Lachman OnCall™. Our Subject Matter Experts (SMEs) understand you need advice right away. Lachman’s SMEs have the knowledge, experience, and skills to address your most urgent scientific, technology, and compliance-related questions, such as: “We had to shut down our sterile manufacturing plant […]

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04
Aug

Webinar: Drug Supply Chain Security Act: Legal Overview and Cross-Enterprise Compliance Strategies (August 11, 2020 @1:00-2:00 PM ET)

In 2019, FDA issued the first Warning Letter for violations of the Drug Supply Chain Security Act, signaling its heightened attention to supply chain and distribution issues. Since DSCSA was enacted in 2013, various provision have come into effect. It is important for companies not just to understand the law’s requirements, but also how to […]

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12
May

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

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

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

(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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23
Apr

Lachman Consultants COVID-19 Survey Results

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
Mar

Coronavirus Readiness

  As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]

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13
Feb
The Queens Guard

Looking at the Sentinel

FDA has announced the 12th Annual FDA Sentinel Public Workshop on April 20-21, 2020. (Please go here for the details.)  The Sentinel System is the largest multi site patient safety database in the world, and includes the Active Post-marketing Risk Identification and Analysis (ARIA) system mandated by Congress in the US Food and Drug Administration […]

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