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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
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    • LSTI Instructors
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How To Build An FDA Audit-Ready QMS — A Primer

This article will address the expected roles of quality control and quality assurance, how these roles are related and how they are different, and how they must work together to create a sound quality management system (QMS).

Posted in: FDA, Manufacturing,
Tags: QA, QC, QMS, quality, quality management,
The Value Of Standardizing Risk Assessment Across Quality Systems

In recent years, the trend in the pharmaceutical, biopharma, and device industries has been to devote more attention to holistic quality systems and to ensure standardization of the company’s overall quality systems rather than using process-by-process policies that may or may not align completely. The 2015 changes to ISO 9001 and ISO 14644-1 and -2 standards have magnified the industry’s focus on risk assessment and quality management systems, integrating and unifying our approach to ensuring quality across all aspects of pharmaceutical, biopharma, and medical device manufacturing.

Posted in: Manufacturing,
Tags: FMEA, QMS, quality management, quality systems, risk assessment,
6 Simple Ways To Get Millennials (More) Invested In Quality

When he was home for the holidays, my 23-year-old son and I had intense, heated discussions about generational differences. We are still on speaking terms, but it got me thinking about how well we understand and value young people — and if we understand the people who make up our future workforce well enough to adequately train them. That is, are we doing everything we can to create a sustainable future workforce that feels valued and — just as important — is engaged, excited, and efficient (the “3Es”)?

Posted in: Manufacturing, Training,
Tags: QA, quality management, training, VQA,
clinical trials landscape
The Changing Landscape Of Clinical Trials: How Leaders Should Respond

The past several years have brought significant changes to the clinical trial landscape. Mergers and acquisitions, new players, the rapid proliferation of technology, increased patient advocacy, and new regulatory guidelines have added to the complexity of trials and burdened resource-strapped leaders with additional challenges and risks.

Posted in: Clinical,
Tags: CRO, provider oversight, quality management, risk, site monitoring,

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

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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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  • 101 Gibraltar Road, Suite 100 Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com

Course Categories

  • Clinical Trials (GCP Training)
  • Coronavirus / COVID-19
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