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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
A Quality Agreement Primer: Managing Risk When Working With Contractors

This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors.

Posted in: Manufacturing,
Tags: contractors, quality agreements, risk, subcontractors,
Overcoming The Challenges Of Patient-Centric Specification Setting

The revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.

Posted in: Clinical, Manufacturing,
Tags: CQA, ICH, patient-centric, QbD, quality by design,
Capacity & Competency Of The Clinical Research Workforce — Today & Tomorrow

It’s not simply an issue of supply and demand. It’s closer to life and death. Put bluntly, we may not be able to keep up with future clinical trial demand because our workforce isn’t growing fast enough. In fact, by some metrics, we’re already falling behind.

Posted in: Clinical, Training,
Tags: clinical research, clinical trial, CRO, drug development, workforce,
Hazmat Regulations: What Life Sciences Companies Need To Know

It is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.

Posted in: Device, Manufacturing,
Tags: CFR, hazardous materials, hazmat, packaging,
COVID-19’s Impact On The Clinical Trial Ancillary Supplies Industry

With restrictions on logistics, and countries implementing new restrictions to address increasing COVID-19 cases, it’s important to understand how to manage clinical trials’ ancillary supplies — like sourcing from the right suppliers, managing distribution to all trial sites, stock management, and response to new regulations.

Posted in: Clinical,
Tags: COVID-19, logistics, pandemic, supplies, supply chain,
How To Generate The Right Input Data For An Effective Quality Management Review System

This article is the second in a two-part series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems. Part 1 discussed the importance of “top-down” quality management and “bottom-up” communication of compliance risks and concerns. Here in Part 2, we turn our attention to the input data for an effective QMR.

Posted in: Manufacturing,
Tags: CAPA, CGMP, compliance, QMR, QMS, quality,
Closing The Perception-Vs.-Reality Gap In CGMP Quality Culture And Compliance

This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

Posted in: Manufacturing,
Tags: CGMP, compliance, inspections, QMS, quality culture,
Is The U.S. Ready For A Re-shored Pharma Supply Chain?

In the first part of this two-part article, we looked at how dependent the U.S. pharmaceutical supply chain is on critical ingredients produced in China and India and the risk that could pose to the nation’s drug supply. In this article, we will examine potential solutions to mitigate those risks and ensure the nation’s drug supply is secure.

Posted in: Manufacturing,
Tags: API, global economy, KSM, supply chain,
Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations

In the long term, as we move into the reopening phases of COVID-19, faced with increased expenses and the challenges with on-site monitoring, clinical research professionals need to ensure their quality management systems have the flexibility for the new normal for site management.

Posted in: Clinical,
Tags: COVID-19, remote monitoring, risk-based monitoring, telehealth, telemedicine,
A Brief History Of Parenteral Process Validation — How We Got Here

Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.

Posted in: Manufacturing,
Tags: guidances, process development, process validation,
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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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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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