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Life Science Training Institute
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  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
      • Clinical Trials (GCP)
      • Manufacturing
      • Medical Devices
      • Regulatory
      • R&D
      • Leadership & Training
    • eLearning
      • Clinical Pathways
      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
    • LSTI Learning Library
    • Training Voucher Packages
    • Checkout
  • Custom Training
    • Live Training
    • Elearning Solutions
    • LSTI Corporate Learning Library
    • CRA Academy
  • Articles & Resources
  • About LSTI
    • LSTI Leadership
    • LSTI Instructors
    • Contact Us
    • Connect with LSTI
    • Frequently Asked Questions
  • Connect

Clinical Trials & Good Clinical Practices (GCP) Training

  • $279.00

    The Impact of “Brexit” On Clinical Research – An Operational Readiness Primer

    Michael Pierro
    Teacher
    0 Available
    seats

    Brexit planning is beginning, but there are many questions in the pharmaceutical and biotechnology industries about what happens between now and when the United Kingdom officially leaves the European Union. Join our 90-minute interactive webinar for an overview of Brexit’s potential impact to current EU clinical development regulations and come up with a plan to be ready!

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  • $279.00

    Conducting an Effective GCP Audit of a CRO-Managed Ongoing Study: Tips and Suggestions

    Michael Pierro
    Teacher
    0 Available
    seats

    While pharmaceutical and biotech companies outsource clinical trial tasks to CROs, Sponsors retain responsibility for the safety of subjects and regulatory requirement compliance and must ensure that the CRO is managing the trial correctly. Join our 90-minute interactive to identify the steps of conducting an effective audit to determine a CRO’s compliance to GCP requirements, study protocol and CRO/Sponsor Contractual Agreements.

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  • $1,799.00

    ICH GCP E6 (R2) Refresher Training Bundle

    $1,799.00 $1,199.00
    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    These seven sessions are intended to give participants a foundational understanding of the recent changes to ICH GCP E6 through the R2 addendum.  You will gain a fundamental understanding of major changes to the guidance, plus major differences between the previous and current version.  You will learn what’s new, what’s important, and how to update your efforts.  This program will be beneficial to literally anyone working with clinical trials.

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  • $279.00

    Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    The recent update to ICH GCP E6 (R2) emphasizes the use of “smarter” onsite, remote and centralized monitoring practices. Join our interactive live webinar to receive a practical guide to implementing an effective monitoring plan.

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  • $279.00

    Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) Addendum

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Investigator Oversight is essential to running an effective, compliant clinical trial. New ICH GCP E6 (R2) guidelines suggest changes in how this should be done. Join us for this interactive session to learn more.

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  • $279.00

    CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Do you have a system in place to prevent noncompliance and to ensure effective action planning with follow-up in the event of a significant deviation? The ICH E6 GCP updates expects that you do!

    Attend our webinar training on the essentials of CAPA and Root Cause Analysis to apply to your clinical trials!

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  • $279.00

    ICH E6 Addendum R2 Team Training and Action Planning

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    The new revision of ICH E6 Guidelines (R2 Addendum) focuses on updating and clarifying standards for sponsor and investigator oversight, quality data characteristics, electronic records and essential documentation. Join our webinar to learn about the major updates to train your team and be ready to implement the guidelines.

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  • $279.00

    CRO Oversight Post ICH GCP E6 (R2) Addendum

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    With the release of ICH E6 R2 GCP update, risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Join us for this 60- minute presentation and be taken through a clinical trial case scenario applying a sponsor oversight plan.

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  • $279.00

    Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Good Documentation Practices are essential to a clinical trial’s success. New ICH GCP E6 (R2) guidelines provide updates and clarity to GCP definitions for documentation.  Join us for this interactive session to learn more.

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  • $279.00

    Quality Risk Management Post ICH GCP E6 R2 Addendum

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Quality Risk Management (QRM) is essential to running an effective, compliant clinical trial.  New ICH GCP E6 (R2) guidelines suggest changes in how this should be done.  Join us for this interactive session to learn more.

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  • $149.00

    Introduction to Biostatistics: 2-Sample Tests and ANOVA

    Robert Parody
    Teacher
    0 Available
    seats

    In this session, you will develop the tools to set-up your hypotheses, identify the correct test to use, complete the test, and make your decision on the hypothesis in question. The course will show you how to translate your statistical answer into one that makes sense in the real world.

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  • $279.00
    surveying

    Performing Risk Assessment Within GCP

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Process and approaches to performing risk assessment in a GCP setting is covered in detail in this session, which is a “must have” to support the transition to clinical quality systems, including clinical quality risk management.

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  • $279.00

    Monitoring Informed Consent (IC): Frequently Asked Questions

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This session focuses on applying a critical thinking technique to confidently address the hard questions regarding informed consent process management. It will give you practical answers to frequently-asked best practice questions related to monitoring informed consent by applying GCP and critical thinking techniques.

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  • $279.00

    Monitoring Electronic Health Records (EHRs): Frequently Asked Questions – Understanding the Recent May 2016 FDA Draft Guidance

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This course will provide attendees with clear, practical answers to Frequently Asked Questions about Monitoring Electronic Health Records (EHR).  Common confusion points about site requirements for source documentation and sponsor monitoring of electronic health records will be discussed in detail.

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  • $279.00

    HIPAA & Source Data Access: Dispelling the Myths

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This course will help you navigate confusing HIPAA requirements and provide solutions to ensure patient data security.  Through instruction and value-added documentation, you will walk away with actionable knowledge to keep your efforts compliant, and have the ability to separate fact and fiction.

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  • $279.00

    Good Documentation Practices for Clinical Trials – Ensuring Air-Tight Results

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This course provides a road map to regulatory and global guideline GDP requirements applied specifically to good clinical practices (GCP) that you can adopt and adapt to your global clinical operations.

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CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials & Good Clinical Practices (GCP) Training (110)
  • Introductory Pharma Courses (18)
  • IT & Data Integrity for Pharma (33)
  • Leadership & Training (40)
  • Manufacturing & Good Manufacturing Practices (GMP) Training (92)
  • Medical Device Training (63)
  • On-Demand Courses (239)
  • Quality (52)
  • Regulatory & Compliance (208)
  • Research & Development (80)
  • Special Packages (5)

Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
  • How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer
  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

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 QMS Quality Quality by Design Quality Risk Management Remote Monitoring Risk Risk-Based Monitoring Root Cause Analysis Site Monitoring SOPs Training Trial Master File

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About Us

The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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Contact Us

  • 19 W College Ave. Ste 300, Yardley, PA 19067
  • +1-267-274-5133
  • info@lifesciencetraininginstitute.com

Course Categories

  • Clinical Trials & Good Clinical Practices (GCP) Training
  • Coronavirus / COVID-19
  • Introductory Pharma Courses
  • IT & Data Integrity for Pharma
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  • Regulatory & Compliance
  • Research & Development
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