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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
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,
Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now

The Drug Supply Chain Security Act (DSCSA) will soon deliver another big impact to both pharmaceutical manufacturers/marketing authorization holders (MAHs) and distributors, with requirements for serialized product verification to comply with the next phase of requirements coming into effect Nov. 27, 2019.

Posted in: Manufacturing,
Tags: distributors, DSCSA, MAHs, serialization, serialized product, verification router service, VRS,
Too Little Or Too Late? Perspectives On FDA’s New Serialization Guidances

Looking forward, the U.S. pharmaceutical industry needs to be aware that despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.

Posted in: Manufacturing,
Tags: distribution, DSCSA, serialization, standardization, supply chain,
Microbial Expectations For 503B Compounding Pharmacies

According to section 503B of the Food Drug and Cosmetic Act, outsourcing facilities are required to comply with all current good manufacturing practices (cGMPs) and regulations regarding insanitary conditions. Many regulatory observations are written for the failure to follow cGMPs and insanitary conditions. This article highlights some of the microbial expectations for 503B compounding pharmacies.

Posted in: FDA, Manufacturing, Training,
Tags: 503B, aseptic, cleanroom, contamination, disinfection, microbial, microorganisims, serialization, sterile, sterility,
risk
Top 10 Risks To Life Sciences Companies In 2018

The new year is just around the corner, signaling a fresh start and new beginning. Janus, the Roman god of new beginnings and namesake of the month of January, likely inspired our familiar tradition of reflection and resolution this time of year. Janus had two faces, which allowed him to look backward to the past and forward to the future.

Posted in: Clinical, Device, FDA, Manufacturing, R&D, Training,
Tags: cybersecurity, opiods, pricing, regulation, risk, risk management, serialization, social media, standards,

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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  • 19 W College Ave. Ste 300, Yardley, PA 19067
  • 215-675-1800 (option 3)
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