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Life Science Training Institute
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      • Clinical Trials (GCP)
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      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
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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

Facilities

  • $279.00

    Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance

    Kelly Thomas
    Teacher
    0 Available
    seats

    Change control is a critical piece of any life sciences activity…and a global regulatory requirement.  Change control deficiencies are mentioned directly or indirectly in most inspection observation findings.  Compliance is a must, and a business imperative.  This course will help you get on the right track with your change control programs, documentation, and overall compliance.

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  • $279.00

    How To Establish The Number of Runs Required For Process Validation

    Mark Allen Durivage
    Teacher
    0 Available
    seats

    During process validation, setting your “number of runs” is critical to establishing defensible efforts in the eyes of regulators.  This session will give you the tools to tailor that number, plus provide best practices.  You will also receive helpful job aids for use long into the future.

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  • $279.00

    Environmental Monitoring (EM) – Establishing and Improving Programs Using a Risk-based Approach

    Kelly Thomas
    Teacher
    0 Available
    seats

    Environmental Monitoring (EM) is a critical component to ensuring microbial contamination control in pharmaceutical product development, research, and manufacturing settings.  Using a risk-based approach to EM can save money while improving efficiencies and product quality.  This webinar will show you how.

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  • $279.00

    Cell Therapy: Process Design Considerations To Support Commercialization

    Erich Bozenhardt
    Teacher
    Herman Bozenhardt
    Teacher
    0 Available
    seats

    Cell Therapy product development and subsequent commercialization holds limitless promise for promoting human health and company profits.  However, it is a difficult and expensive task…unless you know what you are doing.  Join us during this 90-minute webinar and discover the most efficient ways to product quality Cell Therapies!

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  • $279.00

    Understanding Cleanroom Microbiology – Building A Foundation For Compliance

    Danielle DeLucy
    Teacher
    0 Available
    seats

    This course provides practical information on contamination control and clean room management. Information is presented for the critical daily aseptic maintenance and housekeeping functions necessary to maintain required cGMP cleanliness levels.

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  • $279.00

    Improving Biological Facility Design: Critical Tips for Compliance

    Erich Bozenhardt
    Teacher
    Herman Bozenhardt
    Teacher
    0 Available
    seats

    This seminar will explore the key design concepts that are currently driving the compliance and operability of business, and an “inside-out” view of a plant’s design model including: Process Core, Facility Design, Facility Operations, HVAC, Utilities, and Construction. The course will explore modern technologies of facility deployment that can rein in costs and reduce schedules to provide you with specific guidelines that drive compliance to a successful conclusion.

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  • $279.00

    Understanding Aseptic Technique & Cleanroom Behavior: Avoiding Human Error

    Danielle DeLucy
    Teacher
    0 Available
    seats

    This course reviews how quality systems help define requirements for aseptic techniques and cleanrooms and how to properly maintain these environments.

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  • $279.00

    Project Management & Execution for Pharma/Biotech Manufacturing Facilities – A Step-by-Step Guide

    Dwipen Ghosh
    Teacher
    0 Available
    seats

    This course is designed to introduce a very practical, systematic approach for project execution with a view to improving the productivity, quality and minimizing rework.

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  • $279.00

    Renovating Pharmaceutical Manufacturing Facilities for Aseptic Fill/Finish: Critical Planning, Execution & Compliance Tips

    Erich Bozenhardt
    Teacher
    Herman Bozenhardt
    Teacher
    0 Available
    seats

    This course will give you the foundational tools necessary to identify changes that need to be made, formulate a concise implementation plan that includes compliance protocols, and allows for continuous improvement.

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  • $279.00

    Aseptic Processing: Preparing Staff and Programs For Compliance

    Joanna Gallant
    Teacher
    0 Available
    seats

    Aseptic processing deficiencies are one of the most cited observations in FDA 483s and warning letters. Since regional regulatory bodies each have their own requirements, staying compliant can be a confusing and complex challenge.

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  • $279.00

    Bioprocess Facility Design – Layout Rules and Configurations

    Erich Bozenhardt
    Teacher
    Herman Bozenhardt
    Teacher
    0 Available
    seats

    Expansions and renovations to existing biological facilities – and construction of new facilities – provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will reduce costs and improve compliance. This webinar will discuss how process and regulations are changing the modern biotechnology facility and process design paradigm.

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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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CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials (GCP Training) (110)
  • Introductory Pharma Courses (18)
  • IT & Data Integrity for Pharma (33)
  • Leadership & Training (40)
  • Manufacturing (GMP) (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

  • 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
  • Manufacturing (GMP)
  • Medical Device Training
  • On-Demand Courses
  • Quality
  • Regulatory & Compliance
  • Research & Development
  • Special Packages

Meet Our Instructors

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