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Founded in 1998 in Dublin, Ireland, Skillpad's team of industry-experienced Subject Matter Experts and Consultants believes Pharma, Biopharma, and Life Science Industry manufacturing companies can achieve production excellence with improved performance, productivity & compliance, as well as reduced losses & down-time, if they have KNOWLEDGE CONSISTENCY in all critical areas of manufacturing operations.

With 25 years in business, and offices in Europe, the USA and Canada, Skillpad has helped customers all over the world with Life Science Industry Knowledge challenges. We are fully dedicated to the idea that Knowledge Consistency is more achievable than ever using the latest technology and advanced knowledge transfer and management tools.

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    Library

    • Overview of GxP

    An overview of the essential principles and regulations of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP), collectively referred to as GxP. This module outlines the importance of these standards in safeguarding drug safety, efficacy, and quality throughout the drug development lifecycle, from research and nonclinical studies to clinical trials and manufacturing. It explores the role of regulatory bodies, such as the FDA and EMA, and highlights the critical consequences of non-compliance, reinforcing the significance of maintaining rigorous compliance in every phase of pharmaceutical production.

    Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.

      Duration: 30 Mins
    Grade: Core Library

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    SKU: GXP-1200-SPL01-EN Categories: , , Tag:

    Description

    Learning Objectives:

    • List the three characteristics that all drug products must possess
    • Describe the drug development and approval process
    • Define GxP and why it is necessary
    • Explain GLP, GCP, and GMP in terms of their specific objectives
    • Describe the functions of regulatory agencies such as the FDA and EMA
    • Describe the consequences of non-compliance with GxPs

    Learner Benefits:

    • Holistic Understanding of GxP Regulations: Develop a foundational knowledge of GLP, GCP, and GMP and their crucial role in ensuring patient safety and product reliability. Learn to appreciate how these regulations impact every aspect of pharmaceutical development and manufacturing.
    • Insight into Drug Development and Approval: Familiarize yourself with the complex journey of a drug product from initial research to post-market surveillance, gaining awareness of the key regulatory milestones and standards enforced by agencies like the FDA and EMA.
    • Critical Awareness of Compliance Impact: Recognize the potential repercussions of regulatory non-compliance, including financial, legal, and reputational consequences. Learn how strict adherence to GxP can prevent costly errors and enhance organizational integrity.
    		 Module Features:

        Animations
       Voice Over
        Knowledge Checks
        Assessments
       SCORM/AICC compatible
        Full Screen

    Keywords

    • Clinical Trials
    • Drug Development Process
    • Drug Efficacy
    • Drug Quality
    • Drug Safety
    • European Medicines Agency (EMA)
    • Food and Drug Administration (FDA)
    • Good Clinical Practice (GCP)
    • Good Laboratory Practice (GLP)
    • Good Manufacturing Practice (GMP)
    • GxP Regulations
    • Nonclinical Studies

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