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INDUSTRY RESOURCES

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,
18
May
An Analysis Of 2017 FDA Warning Letters On Data Integrity

Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.

Posted in:FDA,Manufacturing,
Tags:ANDAs,data integrity,failures,warning letters,
17
May
Do New Standards Make It Easier To Involve Patients In Research?

“Researching and developing new, life-changing medicines is best when done collaboratively. Today’s announcement from the NIHR [National Institute for Health Research] sets out clear standards for how the pharmaceutical industry should work with patients to develop better vaccines and medicines.”

Posted in:Clinical,
16
May
MHRA Ramps Up Data Integrity, Global Supply Chain Security Efforts

Learn what U.K. Medicines and Healthcare products Regulatory Agency (MHRA) Senior GMDP (good manufacturing and distribution practices) Inspector Tracy Moore had to say about MHRA’s efforts in the areas of drug/device supply chain security and international efforts on harmonization of data integrity guidance.

Posted in:Manufacturing,
Tags:data integrity,GMP,supply chain,
15
May
What’s The Right Pricing Strategy For Cell And Gene Therapies?

At the BIO-Europe Spring Conference in Amsterdam in March 2018, CRA hosted a special program where attendees from biotech, Big Pharma, healthcare provider/payer groups, and patient associations were asked to share their views on pricing strategies for innovative medicine, including cell and gene therapies. More than 60 attendees responded to a series of questions about drug pricing, with a focus on cell and gene therapies, and their responses were captured live through an instantaneous voting system during a panel session.

Posted in:Manufacturing,
Tags:big pharma,cell and gene therapies,pricing,

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