Leadership & Training

LSTI is a leading training and consulting company for leadership and training for life science professionals and pharmaceutical, medical device, and biotech companies.

Are you certain your leadership skills are taking your team to the next level? Does your team have the skills needed to execute your vision?

Contact the Life Science Training Institute for your training needs.

Our trainers are industry subject matter experts (SMEs) who average over 20 years of life science and pharmaceutical experience.

Browse our leadership and training courses below.

$279.00

How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer

(1)

Kathleen Warner

Teacher

0 Available
seats

This course provides an introduction to FDA’s new guidance on computer software assurance (CSA). This guidance is planned for release in February 2021. In preparation for its release, the course will discuss the who, why and what you will need to know to transition from traditional computer system validation (CSV) to CSA.

$179.00

It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020

(1)

Sandra “SAM” Sather

Teacher

0 Available
seats

The updated ISO 14155:2020 – GCPs for Medical Devices standard – has arrived as of July 2020. For medical device and combination product clinical researchers, compliance with (and training for) the standard is required. This webinar will provide you with a comparison of the 2011 and 2020 versions of ISO 14155 to assist you with gap analysis, process improvement, and updates for your clinical trial quality systems. This course also provides guidance to ensure oversight, adequate monitoring, and quality conduct of your medical device trial to meet the updated standard.

$179.00

Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

Sandra “SAM” Sather

Teacher

0 Available
seats

A new ICH E6 Good Clinical Practice (GCP) revision linked to the revised ICH E8 (R1) Guideline “General Considerations for Clinical Trials” is due to be finalized soon. These changes are coming during (or soon after) the COVID-19 pandemic which hugely tested GCP systems, revealing that many are not well equipped to adapt to risk. Join us for this 60 minute session where you will learn where these guidances are headed…and what you can do immediately to prepare.

$179.00

Critical Documentation of Clinical Trial Activities and CAPA During and Post COVID-19 Restrictions

Sandra “SAM” Sather

Teacher

0 Available
seats

This course discusses the need for quality documentation of events that occurred during the crisis that are linked to significant risks and issues that matter. You will review important actions and documentation between various stakeholders (read: sites and sponsors, CROs and sponsors, etc.) which must happen to ensure deviation identification, root cause analysis (RCA), and Corrective and Preventative Actions (CAPA) are handled in a compliant fashion.

$279.00

Clinical Research Project Management – 7 Breakthrough Behaviors For Success

Dalfoni Banerjee

Teacher

0 Available
seats

Clinical project management is a marathon…not a sprint. However, the road isn’t always flat. Distractions, obstacles, pitfalls, and budget overruns can thwart even the best project manager. However, seven simple behaviors can eliminate this problem. This session will outline these behaviors, why they are critical, and help you implement them to ensure the efficiency and efficacy of your clinical trials.

$279.00

Clinical Quality Management Systems (QMS): Establishing a Practical & Compliant Program

Penelope Przekop, MSQA, RQAP-GCP

Teacher

0 Available
seats

Many small to mid-sized biotech and pharmaceutical companies possess exciting science, promising products, and endless opportunity. However, most lack the kind of robust clinical Quality Management Systems (QMS) required by global health authorities. Since patients and profits are at risk, it is critical to establish these systems for market approval and patient safety. This course will give you the necessary tools to establish a working and compliant QMS for your business.

$279.00

Blockchain Technology for the Life Sciences: A Comprehensive Primer

Brooke L. Casselberry

Teacher

0 Available
seats

This course will explore areas within the life sciences where early adoption is a possibility. A vendor-neutral review of current Blockchain software platforms and their potential fit within your organization will be provided. Finally, you will receive instruction on how to identify and execute the steps necessary for determining if Blockchain is applicable to your function within your organization.

$199.00

Measuring Medical Affairs Success – Identifying the Key Performance Indicators (KPIs) for Successful Teams

(1)

Natalee Kestler

Teacher

0 Available
seats

Staffing for Medical Affairs (MA) teams is never easy. This course will outline what core competencies you should covet in the Medical Affairs role. These include intrinsic personality traits, experience, and more. The content will also allow you to identify and seek the qualities needed for your ideal MA to work in your specific environment.

$279.00

Developing a Part 11 Compliance Plan in Clinical Research

Lisa Olson

Teacher

0 Available
seats

This course will describe considerations for developing a plan for Part 11 compliance that prioritizes activities based on risk and importance for organizations involved in clinical research. Participants will learn how to identify which computing systems and service providers fall under Part 11, what SOPs they’ll need, and activities that should be conducted for their current systems.

$279.00

Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs

Penelope Przekop, MSQA, RQAP-GCP

Teacher

0 Available
seats

Pharmaceutical and Biotech Clinical R&D and Pharmacovigilance (PV) Subject Matter Experts (SMEs) are often in the hot seat during internal audits and regulatory inspections. Diligent, proactive companies provide various levels of inspection readiness for many employees, particularly those in middle management. The top inspection readiness priority is to avoid observations by preparing on various levels. This is great! However, audits and inspections do result in observations for many companies. With the increasing number of life sciences companies – and vendors that support them – training on how to develop and write an appropriate Corrective and Preventative Action Plans (CAPAs) is critical. Don’t find yourself beautifully prepared for your audit or inspection, yet unprepared for the aftermath. Join this webinar to learn best practices for preparation.

$279.00

Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works

Joanna Gallant

Teacher

0 Available
seats

Increasingly, global regulators want to know how effective your Corrective and Preventative Actions (CAPA) are. Investigators will look at this specifically because it will give them a comprehensive window into the steps you take leading up to measuring your CAPA effectiveness. These include Root Cause Analysis investigations, and determining CAPAs. After all, you can’t measure the effectiveness of a CAPA if the CAPA was incorrect to begin with. This webinar will show you how to measure CAPA efficacy AND ensure that you take the right steps to get to that point.

$279.00

Note to File 101: Critical Steps for When, and When Not To, Engage in NTFs

0 Available
seats

How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself? The intent of the note to file (NTF) is to clarify an irregularity in trial documentation or conduct, but when used too frequently or inappropriately, NTFs can highlight unresolved problems, add confusing or extraneous information, or take the place of necessary corrective action.

$199.00

Building a Best in Class Medical Affairs Organization: Strategies for Success

(1)

Judith Serafin

Teacher

0 Available
seats

Medical Affairs Organizations are a growing requirement for pharma/biotech firms. However, starting them is never easy. This course will provide an overview of what great Medical Affairs organizations look like, how to build one, and where to start. This is the second session of our comprehensive nine-part certificate series.

$199.00

The Value of the Medical Affairs Organization: A Comprehensive Overview

Judith Serafin

Teacher

0 Available
seats

As the gap between drug production and the patient shortens, strong Medical Affairs programs are more important than ever. This course will provide an overview of what great Medical Affairs organizations look like, their core activities, and the value they provide. This is the first session of our comprehensive nine-part certificate series.