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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

    It’s Ten O’Clock. Do You Know Where Your Trial Master File Is?

    (1)
    Carmella Britt
    Teacher
    0 Available
    seats

    This session is aimed at sponsors who want to bring some discipline back to their TMF and at CROs and other vendors who want to partner effectively with them.  We’ll cover industry standards for content; document handling for electronic/paper hybrids; best practices for corralling TMFs dispersed across multiple vendors; and techniques for ensuring that substantive issues are well-documented.

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  • $279.00

    Project Management: Best Practices for Validation & Regulatory Projects

    Bruce Fieggen
    Teacher
    0 Available
    seats

    In this course, you will learn to navigate common challenges faced when planning/executing regulatory and validation projects, ensuring that they are completed on time and within budget.

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  • $897.00

    Clinical Regulatory Document Management Compliance Professional (CRDMCP)

    $897.00 $799.00
    Daniel Orfe
    Teacher
    Betsy Fallen
    Teacher
    0 Available
    seats

    Successful completion of these three training sessions is intended to meet the needs of individuals who are either new to biopharmaceutical-based document management, Information Management, and regulatory submission publishing for health authorities, or already experienced in one area and looking to gain a broader understanding of the full continuum of regulated document and submission production activities.

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  • $279.00

    Building a Quality Risk Management Program and Leveraging Technology for Risk Based Monitoring

    Angie Maurer
    Teacher
    0 Available
    seats

    Risk-Based Monitoring (RBM) is changing the way companies are conducting clinical trials. Adopting RBM requires changes to a company’s processes and tools for monitoring. Building a quality risk management program and implementing technology will be critical in strategies to increase quality and efficiency and deliver accurate analyses of clinical study site performance and data quality.

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  • $279.00

    Regenerative Medicine: Understanding the Regulatory Landscape

    Kelly Lightfoot
    Teacher
    Andrew Ittleman
    Teacher
    0 Available
    seats

    To help you navigate the confusing waters of bringing regenerative medicines to market, LSTI has partnered with the law firm of Fuerst Ittleman David & Joseph, PL to offer a webinar that will help you make sense of the pending regulatory landscape so you can be prepared for any eventuality.

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  • $279.00

    Effective Clinical Investigator GCP Training – Getting It Right The First Time

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    This Investigator Good Clinical Practice (GCP) course takes the requirements of GCP for clinical trials found in ICH E6 GCP related to the role of the investigator working on a clinical trial for a sponsor/CRO. The required activities related to the investigator GCP roles and responsibilities are presented with case studies to reinforce key concepts and emphasize critical activities that if not performed well or delegated appropriately for a study, can be increase risk toward maintaining protection of human subjects and ensuring data integrity.

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  • $279.00

    CRO Selection and Oversight – A Risk-Based Approach

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Risk management practices are now expected to be incorporated into the clinical quality system of all clinical research stakeholders.  This includes procedures for selection and oversight of CROs and other vendors.

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  • $279.00

    CRA Oversight – A Risk-based Approach

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Using a “risk-based” approach has paid big dividends in clinical trials, as its principles are applicable to many different functional areas.  This is no more visible than when applied to the oversight of Clinical Research Associates (CRA).

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  • $279.00

    A Risk-based Study Management Approach for Clinical Trial Sites

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    Quality risk management must now be a focus of any clinical quality system for all stakeholders, including investigative sites.  Most sites have not incorporated the benefits of a risk-based approach to study conduct.

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  • $279.00

    Understanding & Implementing The Revised NIH & FDA Clinical Trial Protocol Template

    Michael Pierro
    Teacher
    0 Available
    seats

    The National Institutes of Health (NIH) and the U.S. Food & Drug Administration (FDA) are suggesting a standardized format for protocols utilized in conducting Phase II and III clinical trials under an IND (Investigational New Drug) or IDE (Investigational Device Exemption).  Investigators applying for NIH grants must use this template.

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  • $149.00

    Good Clinical Practices (GCP) Overview for Clinical Research Professionals – A Global Primer

    Michael Pierro
    Teacher
    0 Available
    seats

    Good Clinical Practices (GCP) are an integral part of your ability to design and execute clinical studies.  The principles behind GCP provide the compliance and regulatory framework for how your trials must be conducted.

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  • $279.00

    Conducting the CRO Pre-qualification Audit for GCP Compliance – Key Risk Factors to Avoid

    Michael Pierro
    Teacher
    0 Available
    seats

    Far too often, companies select and contract with a Contract Research Organization (CRO) without conducting a “due diligence” audit for GCP compliance.  Even when sponsor firms do audit potential CRO partners, the review is often substandard or misses key GCP qualification points, ultimately putting deliverables, data, and other critical activities at risk.

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  • $279.00

    Clinical Study Requirements – Understanding Differences Between the US and EU

    Michael Pierro
    Teacher
    0 Available
    seats

    Even with increased efforts to harmonize regulatory requirements between the US and European Union, the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) have different requirements for initiating and conducting clinical trials for medicinal products.  Deciding which standards to follow and how to harmonize/organize your own efforts is a daunting task.

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  • $279.00

    Quality by Design (QbD) in Clinical Trials – Build Bullet-Proof Protocols

    Peter Schiemann
    Teacher
    0 Available
    seats

    This seminar will provide attendees with a strong foundation for identifying and managing important risks to quality in the protocol development process.

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  • $279.00

    Strategic Clinical Project Management: Principles and Practical Applications

    Lydia Dyett
    Teacher
    0 Available
    seats

    A review of case studies from failed clinical projects shows that the most costly decisions happen at the beginning.  When you strategize and keep the most critical factors in mind, you will set yourself up for greater success, and this session will start you on that path.

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  • $279.00

    Partnership Strategies with CRO/Vendors: Create Relationships that Create Results

    Keri Urwin
    Teacher
    0 Available
    seats

    This detailed, 90-minute session will help you navigate complex relationship strategies with CRO/Vendors and brainstorm ideas to set you up for success.

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

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