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instruction from the best Subject Matter Experts in pharma, biotech, and med device.

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features for the adult learner including polling, break-outs, and assessments.

LIFE SCIENCE TRAINING INSTITUTE

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INDUSTRY RESOURCES

What Role Should Your Suppliers Play In Single-Use Equipment Validation?
14
Jun
What Role Should Your Suppliers Play In Single-Use Equipment Validation?

In the ongoing battle to cut costs while delivering quality and technically sound product, the biotech industry has spent the past two decades gradually moving toward single-use pre-sterilized plastic equipment for both clinical batch and, where applicable, production scale manufacturing. Single-use process equipment can be used and then disposed of, eliminating the development time to validate the sterilization and in-facility sterilization downtime, as well as development time to qualify and verify the cleaning and commensurate cleaning downtime.

Posted in: Clinical, FDA, Manufacturing,
Tags: biopharmaceutical, biotech, manufacturing, pharmaceutical, single-use,
orphan drug act
14
Jun
Lessons In Navigating The Increasingly Complex World Of Orphan Drug Commercialization

Prior to the passage of the Orphan Drug Act of 1983 (ODA), a meager 38 orphan drugs (ODs) were approved, corresponding to — at best — an approved drug for less than 1 percent of an estimated 7,000 orphan diseases.

Posted in: FDA, Manufacturing,
Tags: OD, ODA, orphan drug, orphan drug act,
CRA
09
Jun
3 Hacks For High CRA Retention

According to the 2016 California Workforce Trends in the Life Science Industry, there were 16,000 statewide life science job postings during the calendar year; 2,732 of those jobs related to clinical trials. In 2015, over 85 percent of life science positions required a minimum of a bachelor’s degree. Hiring managers expect the strong demand for talent to continue until 2018.

Posted in: Clinical,
Tags: clinical research, CRA,
05
Jun
Cell Therapy: Process Design Considerations To Support Commercialization

Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve.

Posted in: FDA, Manufacturing,
Tags: biopharmaceutical, cell therapy, commercialization, FDA, logistics, manufacturing,
19
May
Practical Considerations For Quality Agreements – Beyond The FDA Guidance

Sponsor companies and contract manufacturing organizations (CMOs) have a lot to consider to develop a clear guide for how their organizations will work together effectively. In this article, practical considerations are explored in addition to the FDA’s updated guidance.

Posted in: Manufacturing,
Tags: FDA, GMP, manufacturing, quality, quality agreements,
16
May
Initial Engagement With A Life Science Consultant: Common Pitfalls & Best Practices
Initial Engagement With A Life Science Consultant: Common Pitfalls & Best Practices May 16, 2017 Posted by: LSTI-Editor Category: Device, Manufacturing, No Comments The role of consultants in the biopharmaceutical and medical device industries is significant. Consultants provide experienced resources in crisis situations, when new facilities are being installed, under circumstances requiring a high input [...]
Posted in: Device, Manufacturing,
Tags: biopharmaceutical, consultant, consulting, medical device, pharmaceutical,

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