DIVERSE

course topics, from R&D and clinical trials to manufacturing, global regulatory, and post-market concerns.

QUALITY

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

ACTIONABLE

content that provides you with practical solutions to the toughest challenges.

INTERACTIVE

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

STAY TUNED WITH US

Subscribe for the latest pharmaceutical, biotechnology, and medical device training courses and special offers.

LIFE SCIENCE TRAINING INSTITUTE

Get to know us (by the numbers).

Life Sciences Industries Covered
Expert Instructors
Courses Run
Past participants

INDUSTRY RESOURCES

24
Jan
How Would Proposed Congressional Price Control Policies Impact Biosimilars?

Sen. Bernie Sanders has introduced three bills aimed at reducing prescription drug prices, two of potential importance to biosimilar developers. This article discusses these cost-containment policies, as well as two other congressional initiatives to watch.

Posted in:Manufacturing,
22
Jan
The One-Hour Study Site Audit

In an effort to tease out the priorities of a clinical study site audit, I asked six of our most experienced GCP auditors the following question:
If you only had an hour to conduct a study site audit, what would you look at?

Posted in:Clinical,Training,
22
Jan
What Suprises GCP Auditors?

Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprises you most about the audits you conduct?

Posted in:Clinical,Training,
22
Jan
Delegation of Authority Log: Tips for Study Monitors

We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principle Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

Posted in:Manufacturing,
18
Jan
Cleaning Process Development: Cleanability Testing And “Hardest-To-Clean” Pharmaceutical Products

Cleanability is clearly an important parameter for determining the hardest-to-clean product for use in cleaning validation studies, and reliable methods for this determination are needed. For any analysis, quantitative methods should be preferred over qualitative methods as they are scientific, not subjective, and allow the easy application of statistical evaluation.

Posted in:Manufacturing,
14
Jan
Are You The Weak Link In Your Own Pharma/Biotech Supply Chain? How To Find Out — And Fix It

A team composed of nearly 70 FDA, pharma/biotech, and medical device leaders — spanning 39 organizations and five countries — have concluded that companies trying to get a handle on issues in their supply chains should focus less on their suppliers and more on themselves as the possible source of the problems.

Posted in:Manufacturing,

WHAT'S YOUR DISCIPLINE?

TESTIMONIALS