Quality

LSTI’s quality assurance webinars and on-demand courses provide life science professionals with a basic understanding of QA best practices.

Our interactive webinars help you expand and refine your QA expertise, enabling your company to be more compliant with regulatory authorities. On-demand courses enable you to receive just-in-time training that best suits your schedule.

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

Browse our QA and QC training courses below.

  • $279.00

    China GCP 2020: Understanding and Implementing New Compliance Requirements

    Heidi Liu
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    While the structure and the content of new China GCP is highly consistent with ICH E6 (R2), there are unique aspects for compliance within the regulatory infrastructure setting in China. Understanding how research institutes and IRBs respond to – and implement – new regulatory expectations from the National Medical Products Administration (NMPA) of China is critical to sponsors and CROs. This course will give you the tools necessary to approach these new mandates for running trials in China.

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  • $279.00

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

    Kathleen Warner
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    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.

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  • $179.00

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

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    Sandra “SAM” Sather
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    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.

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  • $179.00

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

    Sandra “SAM” Sather
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    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.

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  • $279.00

    Quality Management of Electronic Systems in Clinical Trial Investigations: A Comparison of FDA and EMA Guidance

    Sandra “SAM” Sather
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    This webinar presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. The session includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials. 

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  • $279.00

    Effective Writing for Investigation Authors and Reviewers

    Monica Guzman
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    If you are working in a regulated life sciences environment and required to write, edit, or review your organizations’ investigation reports, this is the webinar for you.  Learn strategies for improved efficiency and effectiveness in your writing process, helping you to write reports that are more readable, easier to follow, and in line with auditor expectations.

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  • $179.00

    Pharmaceutical Sampling Plans – Understanding for Compliance

    Mark Allen Durivage
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    The use of acceptance sampling is common in the life science industries. Understanding sampling plans and their linkage to risk is a key to compliance. This course will provide you with how to maximize the effectiveness of your sampling plans to mitigate risk and ensure compliance.

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  • $179.00

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

    Sandra “SAM” Sather
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    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.

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  • $179.00

    Conducting a Virtual GCP Audit of a CRO Managed Study During the COVID-19 Pandemic

    Michael Pierro
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    Most pharmaceutical and biotech companies (sponsors) outsource the management and conduct of their clinical trials to a Contract Research Organization (CRO).  Although sponsors can delegate tasks to a CRO, they continue to be responsible for subjects’ safety and overall trial compliance to regulatory requirements.  This is a difficult task under normal circumstances, but seemingly impossible under current COVID-19 travel restrictions.  Even with this challenge, global health authorities will still expect sponsors to have complete and uninterrupted oversight of their CRO partners.

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  • $179.00

    Remote Auditing for GMP Compliance During COVID-19: Challenges and Opportunities

    Mark Allen Durivage
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    Good Manufacturing Practice (GMP) audits can be difficult under normal circumstances, but especially under mandated quarantine periods like the current COVID-19 crisis.  Remote audits allow an organization a viable alternative to ensure continued compliance with GMP by leveraging modern technologies and best practices.  This course will show you how to stay compliant while fulfilling audit responsibilities remotely.

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  • $179.00

    Remote Monitoring Operations While Maintaining HIPAA and GCP During COVID-19 Restrictions

    Sandra “SAM” Sather
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    The recent COVID-19 outbreak has disrupted clinical trials drastically. Monitors are grounded but data still needs to be monitored. FDA has put out the guidance for the industry about COVID-19 and patient safety. The question remains – how do we do this without putting our monitors or trial subjects at risk while staying compliant? This course outlines real solutions for compliant remote monitoring during the Coronavirus quarantine.

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  • $279.00

    Drug Substance Quality Risk Management: A Practical Approach to Identify Critical Quality Attributes and Critical Process Parameters

    Kevin Wall
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    The course presents a practical approach to identify critical variability in the drug substance product and process.  The process begins with identifying the Critical Quality Attributes of the API and ends with defining critical process parameters.  The output is the basis of the CMC control strategy.

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  • $279.00

    Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in!

    Sandra “SAM” Sather
    Teacher
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    Risk-based Monitoring (RBM) is a practice embraced by industry and global Health Authorities. Educating and supporting current resources is a significant challenge for sponsors/CROs and investigation sites and has been a root cause of weak ineffective study start-up efforts. This course will help you train staff to ensure robust RBM activities and ensure success.

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  • $279.00

    Applying Six Sigma Tools and Concepts in Clinical Research: A Process Improvement Guide

    Betsy Fallen
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    Six Sigma is a well-known certification within the manufacturing world, but it’s concepts and practices that can easily be applied to routine activities in clinical research.  This course will introduce you to several tools that have been recognized in Six Sigma certification training.  The curriculum will demonstrate how simplified, modified versions of these tools are already in use, and guide you on identification and use.  Upon completion, you will have actionable, practical Six Sigma tools to bring to bear on your clinical operations – from Sponsor to Site.

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  • $279.00

    Essentials of Disinfectant Efficacy Testing: Ensuring Microbial Control

    Crystal Booth
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    Disinfectant efficacy testing is utilized to measure the effectiveness of chemicals that are used clean, sanitize, or disinfect surfaces. Understanding the importance of testing and proper use of disinfectants is essential in avoiding regulatory findings. This webinar will review the essentials of disinfectant efficacy testing.

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  • $279.00

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

    Penelope Przekop, MSQA, RQAP-GCP
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    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.

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