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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

    Update to ICH GCP E6 (R2) – Final Changes and Implementation

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This 90-minute course will give you practical answers to frequently-asked best practice questions regarding the new responsibilities outlined in ICH 6 for sponsors, investigators/sites and monitors.

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  • $279.00

    FINAL Risk-based Monitoring Guidance: Updates, Impact & Analysis on Clinical Monitoring Systems

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This course presents a succinct review of the differences between the draft and the final guidance, an example of an industry impact analysis, and finally a gap analysis tool to help guide decision-making and implementation planning.

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  • Free

    GCP Refresher Course

    $0.00
    Sandra “SAM” Sather
    Teacher
    0 Available
    seats
    View our 23-minute GCP refresher course! You’ll learn about recent updates to GCP in this short course from the LSTI webinar series. Select the "Purchase Course" button to download this course for free. Immediately after submitting your order, you'll receive a link to download access instructions for the webinar. The Life Science Training Institute’s GxP [...]
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  • $149.00

    Introduction to Biostatistics: Hypothesis Testing

    (1)
    Robert Parody
    Teacher
    0 Available
    seats

    This session will give you 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.  Additionally, the course will aid you in turning your statistical data into an answer that will make sense in the “real world.”

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  • $149.00

    Introduction to Biostatistics: Collecting and Summarizing Data

    Robert Parody
    Teacher
    0 Available
    seats

    This session will give you the tools to interpret data, detect errors, and help you organize your data in an easy to understand format.  This course will give you a foundation in biostatistics by detailing numerical summaries like mean, median, mode, variance, standard deviation, range, interquartile range (IQR), and coefficient of variation (CV).

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  • $279.00
    clipboard

    Regulatory GCP Inspections: Preparation, Participation & Follow-up

    (1)
    Michael Pierro
    Teacher
    0 Available
    seats

    Good Clinical Practice (GCP) inspections – announced or otherwise – are a fact of life and will affect your clinical research activities. Recognizing both US Food & Drug Administration (FDA) and European Medicines Agency (EMA) GCP inspection trends and procedures will keep your firm compliant.  This course will show you how to prepare for, manage, and follow up with a health authority GCP inspection.

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  • $279.00

    FDA’s eCTD Ad-Promo Guidance Is Finalized: Are You Ready?

    Dale Cooke
    Teacher
    0 Available
    seats

    FDA finalized its guidance on submitting promotional materials using the Electronic Common Technical Document (eCTD). Beginning on June 24, 2021, all required submissions of promotional materials must be filed using the eCTD format. That means companies need to start acting now to ensure they’re prepared for this sea change in the way FDA receives promotional materials.

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  • $279.00

    Regulated Clinical Documentation And Content – Purpose, Proper Handling, And Metadata

    Daniel Orfe
    Teacher
    Betsy Fallen
    Teacher
    0 Available
    seats

    This session will be valuable to clinical trials and associated/related personnel looking for a foundational understanding of Trial Master Files (TMF), electronic Trial Master Files (eTMF), and inspection readiness.

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  • $279.00

    Electronic Informed Consent: New Guidance-Implications and Implementation

    Betsy Fallen
    Teacher
    0 Available
    seats

    This course  will address the implementation logistics of the questions answered by the FDA in the guidance, to allow you to develop an implementation plan for the short and long term. Come to this session to learn how to take the FDA recommendations into specific industry settings including sites, sponsors and IRBs.

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  • $279.00

    The Global Development Plan (GDP): Your Roadmap To Drug/Device Development

    Albert Yehaskel
    Teacher
    0 Available
    seats

    This webinar will look at the different components of a development plan and review the information needed to capture the essence of your project.  Additionally, this course will enable you to have an appreciation and understanding of the processes and the various facets associated with planning for successful drug development.

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  • $279.00

    The Investigator Meeting – Regulatory Requirements and Obligations that Ensure Success

    Albert Yehaskel
    Teacher
    0 Available
    seats

    This webinar will provide an overview of the Investigator meeting and how it should be conducted.

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  • $279.00

    The Investigational New Drug (IND) Submission – Tips to Win the First Time

    (3)
    Albert Yehaskel
    Teacher
    0 Available
    seats

    This course will enable the you to have an appreciation/understanding of the IND process.

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  • $279.00

    Successful FDA Interactions – Practical Approaches to Ensure Positive Outcomes

    Albert Yehaskel
    Teacher
    0 Available
    seats

    The course will explore each interaction separately, taking a specific look at important strategies to help you shape and deliver your message.  By attending this course, you will know what to say, what not to say, how to say it, and which communication vehicle will best suit your needs.

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  • $1,350.00

    Clinical Finance: Key Strategies to Stay in Control of Your Study Budget

    Dyana Boutwell
    Teacher
    0 Available
    seats

    Whether you are kicking off a new project, trying to regain control of ongoing study financials, or just trying to gain best practices, this session will help reduce unpredictable scope increases and “wow” change orders, keeping you on top of your budget through your trial.

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  • $279.00

    FDA’s Mandate Requiring Conformance to SEND and SDTM for Pharma Submissions: What is the Vision?

    Laura Kaufman
    Teacher
    0 Available
    seats

    In this course, we will examine the “why” behind the mandate and how it can change the way therapies are being developed, leading to faster market delivery of better drugs. We will explore FDA’s vision of having electronic access to all submission data in ways that are not currently feasible. The electronic standards for exchange of nonclinical data (SEND) and clinical data (SDTM), developed by CDISC, will be discussed, focusing on SEND.

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  • $279.00

    Shed the Weight! Developing Standard Operating Procedures According to Lean Principles

    Denise Lacey
    Teacher
    0 Available
    seats

    This 90-minute webinar will provide you with guidelines for implementing lean principles in your company’s quality system.

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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

Your Courses

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
  • Leadership & Training
  • Manufacturing & Good Manufacturing Practices (GMP) Training
  • Medical Device Training
  • On-Demand Courses
  • Quality
  • Regulatory & Compliance
  • Research & Development
  • Special Packages

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