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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
Measuring COVID-19’s Impact On Availability Of Drugs And API From India And China

COVID-19 has caused an increase in demand for APIs and drugs; those used as antimalarials are seeing the highest demand, followed by bronchodilators, antibiotics, and antivirals. This article reviews the drugs and API in demand globally, with assessments of their supply status in India and China.

Posted in: Manufacturing,
Tags: API, COVID-19, critical drugs, drug shortage,
What To Expect From The FDA During (And After) COVID-19

During a recent Halloran Virtual Town Hall meeting, a panel of experts to share what they are seeing in terms of regulatory activity, as some cases are receiving expedited feedback, while others are experiencing delays in reviews and receipt of commentary from the FDA. This article presents some key insights from the panel’s experience conducting regulatory activities during the pandemic.

Posted in: Clinical, FDA, Manufacturing,
Tags: CBER, CDER, CDHR, COVID-19, FDA,
Applying Aseptic Practices To Protect Yourself From COVID-19

During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. This article focuses on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help you dodge the COVID-19 bullet.

Posted in: Manufacturing,
Tags: aseptic, cleanroom, COVID-19, hygiene,
An Introduction To Quality Agreements For Pharmaceutical Outsourcing

Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.

Posted in: Manufacturing,
Tags: CGMP, CMO, ICH guidance, quality agreements,
Identifying Difficult-To-Clean Or -Inspect Surfaces In Manufacturing And Packaging Equipment

This article describes a practical risk-based approach for assessing and identifying the surfaces, areas, or sites of manufacturing and packaging equipment that are cleaned upon completion of oral solid dosage manufacturing production.

Posted in: Manufacturing,
Tags: direct product contact, DPC, indirect product contact, IPC, NPC, on-product contact, packaging equipment,
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,
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,
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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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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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