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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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    Executive Responsibility in Pharma Manufacturing

    Overview of the regulatory responsibilities of executive management in the pharmaceutical manufacturing industry. This Module explains FDA and legal requirements and the corporate and personal consequences of non-compliance.

      Duration: 30 Mins

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    SKU: RGM-1200-SPL02-EN Category: Tag:

    Description

    Learning Objectives:

    • Explain the relationship between a pharma company’s Executive Management and the FDA
    • Describe the purpose and function of the FDA
    • Describe 3 types of FDA inspection and the purpose of each
    • Explain FDA 483s, Warning Letters, and Consent Decrees
    • Explain the terms ‘Quality Policy’ and ‘Quality System’
    • Describe the characteristics of a properly functioning Quality System
    • Explain why documentation is so important in a Quality System
    		 Module Features:

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

    Keywords

    Consent Decree
    Debarment
    Criminal Prosecution
    Executive Management
    FDA
    Compliance    		 FDA 483
    Food Drug and Cosmetic Act
    GMP
    Personal Responsibility
    Quality Policy
    Quality System

     

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