Clinical Trials (GCP Training)

Good Clinical Practices (GCP) ensure patient safety and product efficacy. Because of this, global health authorities require GCP training for companies in the life sciences, biotech, and medical device industries.

Life Science Training Institute creates live and on-demand training solutions for individuals and organizations working with GCP.

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

Browse our clinical and GCP training courses below.

  • $279.00

    China GCP 2020: Understanding and Implementing New Compliance Requirements

    Heidi Liu
    Teacher
    0 Available
    seats

    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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  • $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.

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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
    Teacher
    0 Available
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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
    Teacher
    0 Available
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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

    Regulatory Affairs in China – The New Drug Regulatory Framework

    Michael Zhang
    Teacher
    Katrin Rupalla
    Teacher
    0 Available
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    This session will introduce the official institutions governing drug development and registration in China and a detailed overview of the requirements laid out in the revised DAL and new DRR for the development of pharmaceutical products.

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  • $179.00

    Pharmaceutical Sampling Plans – Understanding for Compliance

    Mark Allen Durivage
    Teacher
    0 Available
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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
    Teacher
    0 Available
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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
    Teacher
    0 Available
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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
    Teacher
    0 Available
    seats

    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
    Teacher
    0 Available
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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

    FDA REMS Inspection Guide: Audit Preparedness Best Practices

    Penelope Przekop, MSQA, RQAP-GCP
    Teacher
    0 Available
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    Following the April 2018 implementation of the FDA compliance program document describing their Risk Evaluation and Mitigation Strategy (REMS) Inspection program, they have been ramping up focus on REMS inspections.  If your company has a planned FDA submission or an existing REMS program in the US, don’t be caught off guard.

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  • $279.00

    Clinical Research Project Management – 7 Breakthrough Behaviors For Success

    Dalfoni Banerjee
    Teacher
    0 Available
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    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.

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  • $279.00

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

    Sandra “SAM” Sather
    Teacher
    0 Available
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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
    Teacher
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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

    Critical Thinking In Clinical Research: A Better Way hot

    Keith Dorricott
    Teacher
    Sandra “SAM” Sather
    Teacher
    0 Available
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    Attend this live webinar, to learn from recognized industry experts about the DIGR-ACT® Solution –  an exciting methodology for supporting critical thinking in risks and issues management specifically designed for the clinical trial professional.

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  • $279.00

    New FDA Draft Guidance: A Risk-Based Approach to Monitoring Clinical Investigations

    (2)
    Sandra “SAM” Sather
    Teacher
    0 Available
    seats

    In March 2019, FDA released a new draft guidance titled “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers” which helps support the 2013 “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” (RBM) guidance.  This new draft guidance is currently open for comment and further underscores FDA’s emphasis on clinical studies being overseen using risk-based techniques.  This session will illuminate FDA’s thinking and help you prepare.

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