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  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
      • Clinical Trials (GCP)
      • Manufacturing
      • Medical Devices
      • Regulatory
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      • Clinical Pathways
      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
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    • Checkout
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  • Articles & Resources
  • About LSTI
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EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications

While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.

Posted in: Device, Manufacturing,
Tags: COVID-19, EMA, MDR, medical device regulations,
Implementing Data Quality By Design For Improved Data Integrity

We must change the way we think. We must stop perceiving our processes as separate from the current supporting and related downstream technology. We must begin to consider and care as much about how our data will be used or interpreted as we do about how we create it.

Posted in: Manufacturing,
Tags: data, data integrity, data quality, QbD, quality by design,
How To Combine Quality Management With Risk-Based Monitoring In Clinical Trials

It is important to understand why risk-based monitoring (RBM) alone is not enough for a trial to succeed and what the industry can do to extend the use of risk-based strategies to ultimately support improved data quality and increased patient safety in clinical trials.

Posted in: Clinical,
Tags: CRO, RBM, RBQM, risk-based monitoring, risk-based quality management,
COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain

To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.

Posted in: Manufacturing,
Tags: hazards, inventory, inventory management, resources, supply chain,
How To Stop Fighting Quality Fires Using Quality Risk Management

Do you like fighting quality fires? Do you enjoy generating meaningless metric reports that no one acts upon? Do you get the most from your quality risk management (QRM) program? This article provides three practical steps for integrating QRM into your quality system to ensure your organization stays on course.

Posted in: Manufacturing,
Tags: CCP, critical control points, QRM, risk management,
How To Facilitate Great Virtual Meetings During A Pandemic (Or Any Other Time)

Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, but now there is a public health imperative, with a large percentage of people working from home. If you are facilitating a risk assessment, a root cause investigation, or something similar, you may need to do a “virtual facilitation” with team members and subject matter experts who are scattered around the world.

Posted in: Manufacturing,
Tags: virtual meetings, work from home,
Understanding 2019 FDA Enforcement Trends — And What They Mean For 2020

The FDA conducted a total of 18,034 inspections in FY2019, off which 6,434 were inspections of biologics, medical device, or drug companies. Those inspections resulted in the issuance of 15,015 warning letters, a slight increase over 2018. The FDA also increased its import alerts, publishing 98 in 2019. This corresponded with a decrease in injunctions and seizures, showing the FDA’s preference for earlier preventive measures over later involvement.

Posted in: FDA, Manufacturing,
Tags: FDA, form 483, inspections, warning letters,
Clinical Operations In The Age Of A Pandemic

The Beat AML (BAML) Master Clinical Trial was focused on efficiency and speed of operations, not on the coronavirus outbreak or pandemics in general. Yet, the model and technologies used by BAML are applicable for biopharma sponsors who want to adapt their clinical operations to support remote monitoring and faster acquisition of data, while preparing for another outbreak or weathering the current crisis.

Posted in: Clinical,
Tags: coronavirus, logs, pandemic, records,
The 4 Stages Of Drug Delivery Device Evolution: An Inhaler Case Study

To illustrate how delivery device development is evolving in practice, we will use the example of respiratory inhalers. This is a well-established treatment modality, with mature technology solutions available, but one where you can envisage a number of future changes enabled by technology.

Posted in: Manufacturing,
Tags: drug device delivery, patient data, user behavior,
Microorganism Challenges On Online Water Bioburden Analyzers: Pitfalls & Best Practices

This the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.

Posted in: Manufacturing, R&D, Training,
Tags: laboratory, microorganisims, online water bio burden analyzers, OWBAs,
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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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