Pharmaceutical industry

01
Jul

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

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)

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

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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03
Dec

The Importance of Hypothesis Testing During Investigations

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

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

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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