Pharmaceutical industry

Lachman Consultant Services, Inc. / Blog / Pharmaceutical industry
03
Aug

Connect with Lachman Consultants at ISPE Singapore Affiliate Conference & Exhibition August 23 – 25, 2023

By    Aug 03, 2023    Biologics Data Integrity Manufacturing News Pharmaceutical industry

Join Lachman Consultant Services, Inc. online and in-person at Suntec Singapore for the 2023 ISPE Singapore Affiliate Conference & Exhibition, August 23rd – 25th. The exhibition showcases the latest technologies and services for pharmaceutical and biomanufacturing. The three-day conference is expected to include more than ninety international exhibitors and sponsors. Lachman Consultants is pleased to […]

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01
Jul

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

By    Jul 01, 2022    ANDAs Compliance Drugs FDA Inspections NDA New Drugs Pharmaceutical industry Regulatory Affairs

In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]

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30
Jun

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 1)

By    Jun 30, 2022    ANDAs Applications Compliance Enforcement FDA Inspections Pharmaceutical industry

When an FDA investigator walks into your facility and informs you that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Paging the employees to inform them of the presence of FDA at the facility is a common occurrence so that […]

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07
Jul

The Importance of Data Integrity Risk Assessment

By    Jul 07, 2021    FDA Pharmaceutical industry

Paul Mason, Ph.D., Lachman Consultants, wrote an article for Contract Pharma covering “The Importance of Data Integrity Risk Assessment.” Here is a brief excerpt from the article: “The FDA and other Health Agencies have an expectation that companies understand the capability of their systems that generate and store data/records including any data integrity risks associated […]

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09
Apr

The Ever-Evolving World of Combination Products

By    Apr 09, 2021    FDA Medical Devices Pharmaceutical industry

Ricki A. Chase, M.S, Lachman Consultants, wrote a recent article for Contract Pharma looking at the benefits and challenges of the trend towards combination products. Here is a brief excerpt from the article: “As the life sciences industries have continued to evolve, the need for ever changing nomenclature has evolved along with it. It was […]

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03
Dec

The Importance of Hypothesis Testing During Investigations

By    Dec 03, 2020    Pharmaceutical industry

Paul Mason, PhD, Lachman Consultants, wrote a recent article for Contract Pharma discussing why it is critical to have controls in place during out-of-specification investigations to provide quality assurance. Here is a brief excerpt from the article: “While being audited by government health agencies, it can be expected that quality investigations will be reviewed since […]

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01
Jun

Data Integrity: Beyond Electronic Records

By    Jun 01, 2020    Data Integrity Laboratories Pharmaceutical industry Regulatory Affairs

Contract Pharma recently published an article written by Timothy Rhines, Ph.D., Director in the Science and Technology Practice of Lachman Consultants. He discusses how to get your data integrity house in order. Here is a brief excerpt from the article: “The global pharmaceutical industry has been grappling with the regulatory agencies’ focus on data integrity […]

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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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