Login Register
Life Science Training Institute
  • 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
  • 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 Better Way To Document QMS Procedures & Work Instructions In Life Sciences Manufacturing

Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is effectively and clearly documenting procedures and work instructions that are easy to understand and execute. This article presents the requirements for documenting QMS procedures and work instructions, and then introduces methods to effectively and clearly do so.

Posted in: Manufacturing,
Tags: documentation, procedures, QMS, quality management system, standards,
Reviewing FY2017 FDA 483s: Training Failures Or A Learning Paradigm?

How do we act on the data of previous 483s? What do we do with that data? Similar to the annual product reviews, we gather data on FDA observations, make graphs, and then … file it away. But there is an alternative.

Posted in: FDA, Training,
Tags: failures, FDA 483, procedures, training,
quality matters
Why You Need A Quality Culture — And How To Attain It

In today’s world of ever-increasing regulatory scrutiny on pharmaceutical quality we have all witnessed first-hand the public relations nightmare of adverse events, drug recalls, and even company closures. In response, pharma companies have set stricter rules and regulations for their employees to follow, to ensure they remain in compliance with regulators and avoid negative inspection results.

Posted in: Manufacturing, Training,
Tags: policy, procedures, quality, quality culture,
error
Human Error Is The Leading Cause Of GMP Deviations – Or Is It?

Think of your company’s deviations. Concentrate on their most common root cause – the one you see most often and have the hardest time fixing. My high-tech-mind-reading-helmet tells me your answer is human error, correct? Magicians aren’t supposed to reveal their tricks, but this one really isn’t much of a trick. Every company wrestles with human error. We know humans have error rates – we’re not perfect. But how many is too many?

Posted in: Manufacturing, Training,
Tags: GMP, procedures, training,

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

Product categories

  • Coronavirus / COVID-19
  • Uncategorized
  • Clinical Trials (GCP Training)
  • Introductory Pharma Courses
  • IT & Data Integrity for Pharma
  • Leadership & Training
  • Live Webinars
  • Manufacturing (GMP)
  • Medical Device Training
  • On-Demand Courses
  • Quality
  • Regulatory & Compliance
  • Research & Development
  • Special Packages

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.

EMAIL COMMUNICATIONS

Get LSTI Email Communications straight to your inbox. Sign Up Here

Contact

  • 101 Gibraltar Road, Suite 100 Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com

Course Categories

  • Clinical Trials (GCP Training)
  • Coronavirus / COVID-19
  • Introductory Pharma Courses
  • IT & Data Integrity for Pharma
  • Leadership & Training
  • Live Webinars
  • Manufacturing (GMP)
  • Medical Device Training
  • On-Demand Courses
  • Quality
  • Regulatory & Compliance
  • Research & Development
  • Special Packages

Meet Our Instructors

Footer logo
Copyright © 1996 - 2020 VertMarkets, Inc. All Rights Reserved.
  • Webinars
  • Custom Training
  • About LSTI
  • Privacy
  • Terms
Search
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok