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INDUSTRY RESOURCES

16
Jan
Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?

Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

Posted in: FDA, Manufacturing,
Tags: biologics license approval, BLA, NDA, new drug application,
13
Jan
Why You Need A World-Class Quality Culture — And How To Build One

The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

Posted in: Manufacturing,
Tags: leadership, quality culture, quality in action, quality system,
07
Jan
Practical Considerations For Adaptive Designs In Clinical Trials

The life sciences industry and academic world seem to produce incredible scientific breakthroughs on a daily, if not hourly, basis these days. The pace of scientific breakthrough is mesmerizing, as a dazzling variety of technologies and studies have helped humans understand the underlying causes of disease. Whether those causes are genetic, environmental, or behavioral, it seems that we have an arsenal of tools to understand much more than ever how we can meet unmet human health needs.

Posted in: Clinical,
Tags: adaptive clinical trial design, adaptive design, clinical data,
06
Jan
Clinical Trial Root Cause Analysis: Can’t We Do Better Than Five Whys?

Many people in our industry have had root cause analysis (RCA) training. It is aimed at helping people understand an issue and the underlying reasons it happened. Once you have those reasons (the “root causes”), you can act on them. This is the most effective way of trying to stop the same issue from recurring. And RCA is now a requirement for serious issues per ICH E6 (R2).

Posted in: Clinical,
Tags: CAPA, CRA, five why's, ICH E6 (R2), RCA, Root Cause Analysis,
30
Dec
The Need For Digital Networks To Support Cell And Gene Therapies

Cell and gene therapies have a level of complexity from a supply chain perspective that needs new approaches, including a high level of information sharing and integration. This topic was covered from different perspectives at two recent conferences.

Posted in: Manufacturing,
Tags: cell and gene, cell and gene therapies, chain of identity, digital networks, supply chain,
27
Dec
An Analysis Of The FDA’s Drug Shortages Root Cause Report

In Oct. 2019, the FDA’s Drug Shortage Task Force published a report that identified root causes of drug shortages across the U.S. healthcare system and made recommendations for effectively resolving those underlying issues. This article summarizes the report’s findings and discusses potential next steps the FDA may take.

Posted in: FDA, Manufacturing,
Tags: drug manufacturing, drug market, drug shortage crisis, drug shortages, supply chain,

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