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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
Are We Adequately Assessing U.S. Pharma Supply Chain Risks?

There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.

Posted in: Manufacturing,
Tags: API, api manufacturing, COVID-19, KSM, supply chain,
Healing From A Pandemic And Building Resilience Into Future Clinical Trials

We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.

Posted in: Clinical,
Tags: COVID-19, pandemic, plan development, site selection, SOPs, study design,
Top 5 Mistakes To Avoid When Measuring Overall Equipment Effectiveness (OEE) In Pharma Packaging

Despite its (apparently) trivial formulation, overall equipment effectiveness (OEE) is one of the most misleading key performance indicators ever used in the manufacturing world. This article examines five common mistakes you’ll want to avoid when dealing with OEE.

Posted in: Manufacturing,
Tags: automation, OEE, overall equipment effectiveness, packaging machine, pharma packaging, serialization,
2 (Major) Impediments To Faster Biopharmaceutical Product Development

As pharmaceutical products have become more complex, many companies have become bogged down in accomplishing their primary mission of launching new products by complex regulatory requirements, convoluted management approaches, and inefficient resources and methods that add time and cost to moving new products from research to the patients.

Posted in: Manufacturing,
Tags: biopharmaceuticals, commercialization, product development, project planning,
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,
How To Accelerate Adoption Of Patient Technology In Clinical Trials

Although the benefits of implementing it in clinical studies are evident, patient technology has yet to make a clear entrance into the clinical arena, as many trials continue to rely on traditional research methodology.

Posted in: Clinical,
Tags: CRO, digital technology, patient technology, PT, PT adoption,
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,
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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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  • 101 Gibraltar Road, Suite 100 Horsham, PA 19044
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  • Coronavirus / COVID-19
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