Topic outline

  • Audit (self-inspection)

    A one-day course presented by former MHRA inspectors. Drawing on a wide range of experience during, regulatory inspections, third party audits and self-inspections (internal audits. This course ensures understanding and the practical application of self-inspections in the workplace.
    Course Code COM-059
    Region

    UK
    Delivery e-Learning
    Role Role: Other
    Competence Compliance
    Sector Sector: Pharmaceuticals

    This Course is Aimed at
    The Responsible Person on a WDA or other key role requiring audit Also suitable for those aspiring to this role.

    Overview

    Help understand and educate on the approach to self-inspections and practical techniques needed to perform self-inspections. Training is designed to help towards understanding the rules and regulations relating to Chapter 8 of the EU Good Distribution Practice Guidelines. The training and exercises are designed to be engaging and provide an insightful look into the thought process of an auditor. 

    Programme Content and Key Areas

    Key topics:

    • Responsibilities of the Responsible Person regarding Self-Inspections
    • Audit Preparation and Planning
    • Conducting and Recording Self-Inspections including exercise
    • Audit (exercise)
    • Continuous Improvement
    • Audit close out and follow-up actions

    Learning Outcomes

    • Understand the structure and mechanisms of the auditing process
    • Prepare self-inspection audit schedules and programmes
    • Perform an effective audit
    • Manage the post-audit activities and follow-up
    • Understand how to review the effectiveness of an organisation’s quality system and implement effective corrective and preventive actions (CAPA) to address any deficiencies or non-conformance issue identified


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