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

01
Jun
Cross-Sector Intelligence: The Prospects For Data Convergence In Biopharma

This two-part series of articles looks at how the application of new technologies around data analytics has proven beneficial for the biopharmaceutical industry and regulators alike. The first article explored how technological advancements such as use of real-time data, predictive modeling, and artificial intelligence are gaining regulators’ acceptance and enabling the more efficient development of effective drugs and treatment solutions. This article examines the current environment of collaboration in the industry, along with technologies that will open opportunities to utilize data across life science sectors, including cross sector intelligence (CSI), the convergence of information across multiple sectors, enabling intelligent data-driven decision making.

Posted in:Manufacturing,
Tags:biopharma,cross sector intelligence,CSI,data,
31
May
CRO Partnerships 101: What Sponsors Need To Know

Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.

Posted in:Clinical,R&D,
Tags:CRO,partners,sponsors,
28
May
Quality Risk Management 101: A Review Of Required Reading For QRM Practitioners

Following the publication of ICH Q9, industry eagerly embraced the opportunity to share ideas and best practices related to QRM. The cadence of publication steadily increased as ICH Q8, ICH Q10, and ICH Q11 emerged, as thought leaders sought to provide practical guidance to industry on the application of QRM. This article will focus on selected publications addressing general, rather than specific, applications of QRM.

Posted in:Manufacturing,Training,
Tags:FMEA,HACCP,ICH Q9,PDA,QRM,quality risk management,
24
May
Assessing The Value Of Wearables In Interventional Clinical Trials

Advancements in biosensor technology are becoming increasingly common in the consumer space, with wrists adorned with Fitbits or similar devices, clothing embedded with “intelligent” fibers, and personal safety devices seen in healthcare facilities across the nation. Our culture is increasingly accustomed to tracking health metrics through smartphones and simple recreational wearables. In the pharmaceutical space, we are now seeing where success in the consumer segment can translate to value-adds for clinical trials.

Posted in:Clinical,FDA,
Tags:data,data analysis,wearables,
23
May
Best Practices In Environmental Monitoring Sampling — Transportation & Analysis

The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification can be broken into six phases to increase the likelihood of success during inspection for licensure of a facility. This article discusses the final two phases.

Posted in:Manufacturing,
21
May
5 Pitfalls To Achieving Proactive Risk Management In Life Sciences Companies — And How To Avoid Them

Pharmaceuticals, large and midsize, have a long history of rewarding reactive firefighting as opposed to proactively identifying problems and preventing issues from occurring. As a result, proactive risk management and the cultural change that goes with it have been a hard sell.

Posted in:Manufacturing,Training,
Tags:adverse events,risk assessment,risk management,value stream analysis,

WHAT'S YOUR DISCIPLINE?

TESTIMONIALS