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.

UPCOMING LIVE COURSES

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

19
Nov
Data Integrity In Clinical Trials: 4 Key Concerns Of The FDA & MHRA

For the first time ever, GCP collaborations between the FDA and Medicines and Healthcare products Regulatory Agency (MHRA) were the focus of a workshop for the drug development industry. In what is projected to be the initial installment in a series, the FDA hosted the MHRA and invited interested individuals to join the workshop “Data Integrity in Global Clinical Trials — Are We There Yet?”

Posted in:Clinical,
16
Nov
Fault Tree Analysis: Uncovering The Root Causes Of More Complex Problems

A refreshed approach to fault tree analysis can be an incredibly helpful addition to your problem-solving armamentarium. Having the confidence to begin using it — or begin using it more often — is the first step toward getting more comfortable with it and mastering its effects and nuances.

Posted in:Manufacturing,
15
Nov
Establishing A Critical Supply Chain For Autologous Cell And Gene Therapies

With the recent breakthroughs in cell and gene therapy, there is increased emphasis on the design and implementation of different supply chain models to support the movement of materials and drug product across the chain of care. Unlike more traditional supply chains, many of these therapies have unpredictable sources and manufacturing and infusion locations. The most extreme example is loosely referred to as the “vein-to-vein” supply chain — particularly for autologous therapies.

Posted in:Manufacturing,R&D,
14
Nov
Help! My Isolator Is Taking Too Long To Degas — What Should I Do?

Probably one of the most significant developments in sterilization and aseptic practices in pharma is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.

Posted in:Manufacturing,
Tags:aseptic,isolator,sterile,vaporized hydrogen peroxide,VHP,
13
Nov
Implementing An End-To-End Clinical Development Process Framework

If we take for granted that there will always be new and changing processes, systems, and digital platforms and the organizational complexity within Big Pharma will not abate, how do we ensure we optimize the entire clinical trial process and make the best use of our technology and process investments?

Posted in:Clinical,
09
Nov
Health-Based Exposure Limits: How Do The EMA’s Q&As Compare With New And Forthcoming ASTM Standards?

The EMA Q&As and their updates mark an important turning point in the pharmaceutical industry regarding cleaning validation and quality risk management. The new ASTM standards will provide guidance to the industry on the appropriate development of health based exposure limits, for the implementation of science- and risk-based approaches to cleaning validation, and on the use of statistical techniques for measuring the risk in cleaning and assessing the effectiveness of cleaning processes.

Posted in:Manufacturing,

WHAT'S YOUR DISCIPLINE?

TESTIMONIALS