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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

    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

    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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  • $279.00

    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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  • $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

    Developing a Part 11 Compliance Plan in Clinical Research

    Lisa Olson
    Teacher
    0 Available
    seats

    This course will describe considerations for developing a plan for Part 11 compliance that prioritizes activities based on risk and importance for organizations involved in clinical research.  Participants will learn how to identify which computing systems and service providers fall under Part 11, what SOPs they’ll need, and activities that should be conducted for their current systems.

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  • $279.00

    Establishing Appropriate Quality Metrics

    Kelly Thomas
    Teacher
    0 Available
    seats

    In 2016, the FDA released a revised draft guidance, “Submission of Quality Metrics Data Guidance for Industry”, describing its Quality Metrics Reporting Program for drugs and biologics. New compliance and inspection policies could be developed as a result of submitted quality metrics. Establishing quality metrics now will help your company prepare for any future regulations as well as drive your Quality Culture toward continuous improvement.

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  • $279.00

    Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs

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

    Pharmaceutical and Biotech Clinical R&D and Pharmacovigilance (PV) Subject Matter Experts (SMEs) are often in the hot seat during internal audits and regulatory inspections.  Diligent, proactive companies provide various levels of inspection readiness for many employees, particularly those in middle management.  The top inspection readiness priority is to avoid observations by preparing on various levels. This is great!  However, audits and inspections do result in observations for many companies.  With the increasing number of life sciences companies – and vendors that support them – training on how to develop and write an appropriate Corrective and Preventative Action Plans (CAPAs) is critical.  Don’t find yourself beautifully prepared for your audit or inspection, yet unprepared for the aftermath. Join this webinar to learn best practices for preparation.

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  • $279.00

    Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works

    Joanna Gallant
    Teacher
    0 Available
    seats

    Increasingly, global regulators want to know how effective your Corrective and Preventative Actions (CAPA) are. Investigators will look at this specifically because it will give them a comprehensive window into the steps you take leading up to measuring your CAPA effectiveness. These include Root Cause Analysis investigations, and determining CAPAs. After all, you can’t measure the effectiveness of a CAPA if the CAPA was incorrect to begin with. This webinar will show you how to measure CAPA efficacy AND ensure that you take the right steps to get to that point.

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  • $279.00

    Note to File 101: Critical Steps for When, and When Not To, Engage in NTFs

    Luisa Monica
    Teacher
    Jackie Morrill
    Teacher
    0 Available
    seats

    How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself? The intent of the note to file (NTF) is to clarify an irregularity in trial documentation or conduct, but when used too frequently or inappropriately, NTFs can highlight unresolved problems, add confusing or extraneous information, or take the place of necessary corrective action.

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  • $279.00

    Right to Try Legislation: Impact on Industry, Health Authorities, and Patients

    Michael Pierro
    Teacher
    0 Available
    seats

    “Right to Try” laws allow terminally and severely ill patients to try medicines that have passed the first phase of the FDA/Health Authority approval process, but have not been fully approved for public use. This session will provide guidance on how to get your product to needy patients in a compliant, responsible, and safe manner.

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  • $199.00

    Building a Best in Class Medical Affairs Organization: Strategies for Success

    (1)
    Judith Serafin
    Teacher
    0 Available
    seats

    Medical Affairs Organizations are a growing requirement for pharma/biotech firms. However, starting them is never easy. This course will provide an overview of what great Medical Affairs organizations look like, how to build one, and where to start. This is the second session of our comprehensive nine-part certificate series.

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  • $199.00

    The Value of the Medical Affairs Organization: A Comprehensive Overview

    Judith Serafin
    Teacher
    0 Available
    seats

    As the gap between drug production and the patient shortens, strong Medical Affairs programs are more important than ever. This course will provide an overview of what great Medical Affairs organizations look like, their core activities, and the value they provide. This is the first session of our comprehensive nine-part certificate series.

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  • $279.00

    Mock Regulatory Inspections: How to Get the Best Bang for Your Buck

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

    Investing in a Regulatory Mock Inspection (Mock) exercise is a trending industry inspection readiness approach. Execution of a Mock based on lessons learned from industry will ensure that your inspection readiness exercise accurately identifies gaps that are truly specific to your organization, providing the most bang for your buck.

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  • $279.00

    Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11

    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    As technology improves, clinical trials are increasingly becoming more “digital.” Compliance therefore becomes more complex and evolves quickly. Everything from patient safety to consumer confidence is at stake. This course will show you how to bring electronic signatures in compliance with FDA 21 CFR Part 11 requirements for electronic records.

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  • $279.00
    knowledge transfer

    Improving Product Quality During Technical Transfer: Minimizing Risk, Maximizing Results

    Eric Good
    Teacher
    0 Available
    seats

    Successful technology transfer in the manufacturing of pharmaceutical products is a stressful and expensive process that is fraught with risk. Whether you are moving from early R&D to producing product for clinical trials, scaling up commercial manufacturing, changing your process, or moving to an outsourced model, careful planning and execution is needed.

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  • $279.00

    Electronic Document Management Systems (EDMS) & Electronic Common Technical Documents (eCTD): An Overview

    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 regulatory requirements, implementation, and best practices surrounding Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD).

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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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