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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

Device

  • $279.00

    The New Medical Device Single Audit Program (MDSAP) for Manufacturers – Analyzing Rewards and Challenges

    Marcelo Trevino
    Teacher
    0 Available
    seats

    In the highly regulated medical device world, standards and regulations are continuously evolving to ensure that the highest levels of quality and safety are achieved. To that end, international regulators have long recognized the value of developing a standardized, global approach to auditing and monitoring medical device manufacturing, and for the last five years, the International Medical Device Regulators Forum (IMDRF) has spearheaded an effort to create such a framework.

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  • $279.00

    Medical Devices: Managing Unannounced Visits from Notified Bodies

    Marcelo Trevino
    Teacher
    0 Available
    seats

    In the highly regulated medical device world, standards and regulations continue to evolve to ensure that maximum levels of quality and safety are achieved. This includes the advent of unannounced audit visits from notified bodies.

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  • $279.00

    Device Compliance Audit Management – Best Practices to Meet Global Regulations and Notified Body Expectations

    Marcelo Trevino
    Teacher
    0 Available
    seats

    In the highly regulated medical device world, most manufacturers have to manage different types of quality system audits in order to comply with many international regulations, which creates a huge burden on staff and budgets.  Through this course, you will be able to benchmark your audit processes in order to improve the efficiency and quality of your audits.

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  • $149.00

    Risk Management for Medical Devices – A Compliance Primer

    Dan O’Leary
    Teacher
    0 Available
    seats

    LSTI offers a convenient online solution to get you and your colleagues up to speed with risk management principles for medical devices.

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  • $279.00

    Risk Management for Medical Devices – Converting to EN ISO 14971:2012

    Dan O’Leary
    Teacher
    0 Available
    seats

    Manufacturers who put the CE Mark on a medical device must bring the risk management file into compliance with the harmonized standard.

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  • $279.00

    Medical Device Complaint Handling and MDR Reporting

    Dan O’Leary
    Teacher
    0 Available
    seats

    This course will help your organization ensure an integrated, efficient, and complaint system.

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  • $279.00

    Design Change Analysis – Top Considerations

    Dan O’Leary
    Teacher
    0 Available
    seats

    A detailed understanding of the design changes you should consider will help you create the most compliant system.

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  • $279.00

    Analyzing and Understanding ISO 13485 Proposed Changes

    Marcelo Trevino
    Teacher
    0 Available
    seats

    In the highly regulated medical device world, standards and regulations are continuously evolving to ensure that the highest levels of quality and safety are achieved. Through this course you will be able to assess your existing quality system processes and understand the changes that will need to be implemented in your organization to comply with the revised ISO 13485 Standard and to meet expectations from notified bodies.

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  • $279.00

    Identifying and Closing the Training Gap in Clinical Research

    Laurie Halloran
    Teacher
    0 Available
    seats

    Sponsors of clinical trials – and organizations that execute clinical trials – consistently identify the need for well trained and qualified people at all levels to execute studies.  Fast-paced clinical trials and the pressures to quickly and effectively meet project milestones can be overwhelming.

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  • $279.00

    Reducing Human Error in Life Sciences Manufacturing

    Joanna Gallant
    Teacher
    0 Available
    seats

    Recent statistics show that human error is the cause of nearly 80% of failures in manufacturing facilities. This poses a tremendous challenge to pharmaceutical, biotech, and medical device companies as it translates to a significant loss of time, money, and consumer confidence each year.

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  • $279.00

    Data Integrity – Detecting & Mitigating Risk

    Joanna Gallant
    Teacher
    0 Available
    seats

    Data integrity is absolutely critical to the quality and efficacy of finished pharmaceutical products.  Pharmaceuticals manufactured without accurate, trustworthy data cost firms millions in fines, lost sales, and general lack of brand confidence.

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  • $279.00

    Understanding the Medical Device Classification System: Best Practices for Selecting the Best Fit

    Michael Drues
    Teacher
    0 Available
    seats

    In this webinar you will learn how to avoid costly mistakes and, more importantly, discover creative ways to use the medical device classification system to your competitive advantage. Simply put, the more effective your classification strategy, the quicker and easier you will get your products to market while making it more difficult for your competitors at the same time –the true art of regulatory strategy.

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  • $279.00

    Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success

    Joanna Gallant
    Teacher
    0 Available
    seats

    Standard operating procedures (SOPs) are a fact of life in regulated industry.  They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections.

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  • $279.00

    The Premarket Notification/510k Submission: Using Substantial Equivalence to your Advantage!

    Michael Drues
    Teacher
    0 Available
    seats

    In this webinar you will learn how to design the substantial equivalence component of a successful 510k submission to get a medical device to market as quickly and efficiently as possible and to avoid problems before they occur.

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  • $279.00

    The Premarket Approval Pathway: Ensure Successful Regulatory Submissions

    Michael Drues
    Teacher
    0 Available
    seats

    This unique seminar demonstrates important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialities.  Strategies for using regulation as a competitive advantage will also be discussed.

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  • $279.00

    Reprocessing Medical Devices: Final Guidance – How To Meet New Validation Requirements

    Michael Drues
    Teacher
    0 Available
    seats

    As medical devices become more complex and expensive, reprocessing becomes more attractive, and mitigating risks is critical.  This session will give you the tools you need to tackle those challenges.

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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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