Clinical Trials (GCP Training)

Good Clinical Practices (GCP) ensure patient safety and product efficacy. Because of this, global health authorities require GCP training for companies in the life sciences, biotech, and medical device industries.

Life Science Training Institute creates live and on-demand training solutions for individuals and organizations working with GCP.

Our trainers are industry subject matter experts (SMEs) who average over 20 years of life science and pharmaceutical experience.

Browse our clinical and GCP training courses below.

  • $199.00

    Remote Monitoring Operations While Maintaining HIPAA and GCP During COVID-19 Restrictions

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    The recent COVID-19 outbreak has disrupted clinical trials drastically. Monitors are grounded but data still needs to be monitored. FDA has put out the guidance for the industry about COVID-19 and patient safety. The question remains – how do we do this without putting our monitors or trial subjects at risk while staying compliant? This course outlines real solutions for compliant remote monitoring during the Coronavirus quarantine.

    See more
  • $279.00

    FDA REMS Inspection Guide: Audit Preparedness Best Practices

    Penelope Przekop, MSQA, RQAP-GCP
    Teacher
    0 Available
    seats

    Following the April 2018 implementation of the FDA compliance program document describing their Risk Evaluation and Mitigation Strategy (REMS) Inspection program, they have been ramping up focus on REMS inspections.  If your company has a planned FDA submission or an existing REMS program in the US, don’t be caught off guard.

    See more
  • $279.00

    Clinical Research Project Management – 7 Breakthrough Behaviors For Success

    Dalfoni Banerjee
    Teacher
    0 Available
    seats

    Clinical project management is a marathon…not a sprint. However, the road isn’t always flat. Distractions, obstacles, pitfalls, and budget overruns can thwart even the best project manager.  However, seven simple behaviors can eliminate this problem. This session will outline these behaviors, why they are critical, and help you implement them to ensure the efficiency and efficacy of your clinical trials.

    See more
  • $279.00

    Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in!

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Risk-based Monitoring (RBM) is a practice embraced by industry and global Health Authorities. Educating and supporting current resources is a significant challenge for sponsors/CROs and investigation sites and has been a root cause of weak ineffective study start-up efforts. This course will help you train staff to ensure robust RBM activities and ensure success.

    See more
  • $279.00

    Applying Six Sigma Tools and Concepts in Clinical Research: A Process Improvement Guide

    Betsy Fallen
    Teacher
    0 Available
    seats

    Six Sigma is a well-known certification within the manufacturing world, but it’s concepts and practices that can easily be applied to routine activities in clinical research.  This course will introduce you to several tools that have been recognized in Six Sigma certification training.  The curriculum will demonstrate how simplified, modified versions of these tools are already in use, and guide you on identification and use.  Upon completion, you will have actionable, practical Six Sigma tools to bring to bear on your clinical operations – from Sponsor to Site.

    See more
  • $279.00

    Critical Thinking In Clinical Research: A Better Way hot

    Keith Dorricott
    Teacher
    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Attend this live webinar, to learn from recognized industry experts about the DIGR-ACT® Solution –  an exciting methodology for supporting critical thinking in risks and issues management specifically designed for the clinical trial professional.

    See more
  • $279.00

    New FDA Draft Guidance: A Risk-Based Approach to Monitoring Clinical Investigations

    (2)
    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    In March 2019, FDA released a new draft guidance titled “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers” which helps support the 2013 “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” (RBM) guidance.  This new draft guidance is currently open for comment and further underscores FDA’s emphasis on clinical studies being overseen using risk-based techniques.  This session will illuminate FDA’s thinking and help you prepare.

    See more
  • $279.00

    Essentials of Disinfectant Efficacy Testing: Ensuring Microbial Control

    Crystal Booth
    Teacher
    0 Available
    seats

    Disinfectant efficacy testing is utilized to measure the effectiveness of chemicals that are used clean, sanitize, or disinfect surfaces. Understanding the importance of testing and proper use of disinfectants is essential in avoiding regulatory findings. This webinar will review the essentials of disinfectant efficacy testing.

    See more
  • $279.00

    Clinical Quality Management Systems (QMS): Establishing a Practical & Compliant Program

    Penelope Przekop, MSQA, RQAP-GCP
    Teacher
    0 Available
    seats

    Many small to mid-sized biotech and pharmaceutical companies possess exciting science, promising products, and endless opportunity.  However, most lack the kind of robust clinical Quality Management Systems (QMS) required by global health authorities.  Since patients and profits are at risk, it is critical to establish these systems for market approval and patient safety.  This course will give you the necessary tools to establish a working and compliant QMS for your business.

    See more