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Life Science Training Institute
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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

Manufacturing & Good Manufacturing Practices (GMP) Training

  • $279.00

    EU vs. US GMP: Understanding Major Differences Post FDA/EMA Mutual Recognition Agreement

    Joanna Gallant
    Teacher
    0 Available
    seats

    While the idea of fewer inspections is a positive for industry – meaning less time will be spent with multiple regulatory agency inspections – each inspection now carries even more weight as it will be accepted by multiple agencies. Understanding both US Food & Drug Administration (FDA) and European Medicines Agency (EMA) GMP regulations is now more important than ever.

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  • $279.00

    Medical Applications in 3-D Printing: Clinical Benefits, Regulatory Issues, and Manufacturing Challenges

    Michael Drues
    Teacher
    0 Available
    seats

    This course will be of benefit to anyone in the life sciences who is interested in 3-D printing as a method for developing a therapeutic product (e.g., medical device, drug delivery system, etc.), including those already using 3-D printing but want a better understanding of FDA’s position on the subject.

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  • $1,350.00

    Auditing Validated Computer Systems In A GxP Environment

    Alecia Adams
    Teacher
    0 Available
    seats

    The purpose of this training is to present techniques and strategies for auditing computer systems validation documentation for compliance to applicable global regulations, plus internal policies and SOPs.   Current issues including cloud systems and data integrity will be discussed.

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  • $279.00

    Drug Development 101 – How A Drug Is Made

    Albert Yehaskel
    Teacher
    0 Available
    seats

    This course will enable you to have an appreciation/understanding of the critical processes associated with drug development.

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  • $279.00

    Laboratory Data Integrity: Current Expectations for OOS Result Investigations

    (1)
    Joanna Gallant
    Teacher
    0 Available
    seats

    In order to assure your firm’s data integrity, staff must be kept up-to-date on the handling of laboratory data/results – especially failing or out of specification (OOS) data. This webinar will cover the current expectations for handling OOS investigations – including the process, roles/responsibilities, and expected outcomes.

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  • $279.00

    Quality Agreements & FDA – What You Must Know to Comply

    Joanna Gallant
    Teacher
    0 Available
    seats

    Don’t wait until an FDA inspection to learn there are deficiencies with your approach to drafting and implementing Quality Agreements!  This course will provide an overview and discussion of significant portions of the guidance.

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  • $279.00

    Reacting to “Human Error” – Moving Beyond “Retraining” As A Response

    (1)
    Joanna Gallant
    Teacher
    0 Available
    seats

    In this interactive webinar, we’ll explore a collection of conditions that can contribute to human error – including identifying the ONE condition where retraining may actually help.

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  • $279.00

    Aging Biotech and Aseptic Facilities – Renovation for Survival

    Erich Bozenhardt
    Teacher
    Herman Bozenhardt
    Teacher
    0 Available
    seats

    This course looks at key design features and philosophies that will drive compliance to a successful conclusion.  Additionally, this session will explore modern technologies of facility redevelopment that can extend the life of a facility by 10 -20 years, enhance compliance to current standards, reduce the operating risks, and provide more robust plant performance.

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  • $279.00

    Organizational Strategies for Reducing Human Error in GMP Environments

    Joanna Gallant
    Teacher
    0 Available
    seats

    Most companies still show “human error” as a leading root cause to programs and issues in their organizations – even though it may not be the case.  What if you could take some proactive steps at the organizational level that would address potential situations commonly seen as “human error” before they occurred?

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  • $299.00

    Data Integrity in a GxP Environment – Top Tips for Compliance

    Alecia Adams
    Teacher
    0 Available
    seats
    Member of the Association for GxP Excellence (AGXPE)? Contact us to learn how you can save 25% on this course. DescriptionWho Should AttendWhat To ExpectDescription COURSE DESCRIPTION OVERVIEW In April 2016, the FDA issued its draft “Data Integrity and Compliance with cGMP Guidance for Industry.” This document quickly followed similar documents issued by other global [...]
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  • $279.00

    Making Training Stick: Ensuring Your GMP & Task Training Is Effective

    Joanna Gallant
    Teacher
    0 Available
    seats

    What does it take for training to be effective, and how do you make it happen? Take this webinar to find out!

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  • $279.00

    Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle

    Joanna Gallant
    Teacher
    0 Available
    seats

    Learn the differences between the old GMP mindset and the new quality systems mindset – and how they both affect our daily operations.

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CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials & Good Clinical Practices (GCP) Training (110)
  • Introductory Pharma Courses (18)
  • IT & Data Integrity for Pharma (33)
  • Leadership & Training (40)
  • Manufacturing & Good Manufacturing Practices (GMP) Training (92)
  • Medical Device Training (63)
  • On-Demand Courses (239)
  • Quality (52)
  • Regulatory & Compliance (208)
  • Research & Development (80)
  • Special Packages (5)

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

TOPICS

Cleaning Validation Cleanroom Clinical Trials Cloud CMOs Computer Systems CRAs CROs Data Integrity Device eCTD EHRs EMA Equipment Facilities FDA GCP GDP GLP GMP HIPAA Human Error ICH Informed Consent Inspections Instructional Design Management manufacturing Marketing MDR microbial control Process Validation Project Management QMS Quality Quality by Design Quality Risk Management Remote Monitoring Risk Risk-Based Monitoring Root Cause Analysis Site Monitoring SOPs Training Trial Master File

Your Courses

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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Contact Us

  • 19 W College Ave. Ste 300, Yardley, PA 19067
  • +1-267-274-5133
  • info@lifesciencetraininginstitute.com

Course Categories

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

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