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Clinical Trials

  • $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.

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  • $279.00

    Blockchain Technology for the Life Sciences: A Comprehensive Primer

    Brooke L. Casselberry
    Teacher
    0 Available
    seats

    This course will explore areas within the life sciences where early adoption is a possibility. A vendor-neutral review of current Blockchain software platforms and their potential fit within your organization will be provided.  Finally, you will receive instruction on how to identify and execute the steps necessary for determining if Blockchain is applicable to your function within your organization.

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  • $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.

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  • $299.00

    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.

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  • 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.

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  • $299.00

    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.

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  • $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.

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  • $279.00

    New FDA Draft Guidance – A Risk-Based Approach to Monitoring of Clinical Investigations

    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.

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  • $299.00

    The MHRA Data Integrity Guidance Clarified: What it Means for Industry & Patients

    (2)
    Betsy Fallen
    Teacher
    0 Available
    seats

    In March of 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) released the “‘GXP’ Data Integrity Guidance and Definitions” guidance document, which outlined the agency’s thinking on data integrity best practices.  In October of 2018, FDA and MHRA held a joint GCP (Good Clinical Practices) Data Integrity Workshop, where the agencies clarified their expectations for data integrity in clinical studies and identified key risk areas using case studies and agency observations.  This course will give you a baseline for data integrity requirements, and overlay lessons learned from the FDA/MHRA workshop.

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CATEGORIES

  • Sales & Marketing (1)
  • Clinical Trials (99)
  • Manufacturing (88)
  • Med Device (55)
  • Quality (39)
  • Regulatory & Compliance (197)
  • Research & Development (70)
  • Leadership & Training (36)
  • IT & Data (31)
  • Upcoming Live Courses (8)
  • On Demand Courses (220)
  • Introductory Courses (19)
  • Special Packages (5)

TOPICS

Cleaning Validation Cleanroom Clinical Trials Cloud CMOs Computer Systems CRAs CROs Data Integrity Device eCTD EHRs EMA Equipment Facilities FDA GCP GDP GLP GMP HIPAA Human Error ICH Informed Consent Inspections Instructional Design Management manufacturing Marketing MDR microbial control Process Validation Project Management Quality Quality by Design Quality Risk Management Remote Monitoring Risk Risk-Based Monitoring Root Cause Analysis Site Monitoring SOPs Training Trial Master File Upcoming Courses

Your Courses

Upcoming Live Courses

  • Clinical Research Project Management - 7 Breakthrough Behaviors For Success
  • Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control
  • The MHRA Data Integrity Guidance Clarified: What it Means for Industry & Patients
  • Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance
  • Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs
  • CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum
  • Medical Device Recalls – Keys To Implementing A Successful Approach

Contact

  • 101 Gibraltar Road, Suite 100. Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com
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