Topic outline

  • WDA holder – GDP and Licence Obligations

    A one-day course, presented by former MHRA inspectors, to develop knowledge and experience at management level. The WDA Licence Holder should have a high level of knowledge to meet their obligations including outsourcing, provision of suitable equipment and facilities, provision of a Quality Management System and appointing a Responsible Person.
    Course Code COM-064
    Region 

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

    This Course is Aimed at

    The Training Course is designed for the WDA licence holder and senior management who may have an indirect impact on regulatory or quality. 

    The course will be adapted to meet the needs of those attending whether from micro or SME companies, or large pharmaceutical manufacturers with a distribution function. 

    The approach used is suitable for companies facing regulatory action and also for companies aiming to maintain and improve their current compliance status.

    Overview

    • Ensure management can effectively support staff in achieving compliance.
    • Support pragmatic decision making in provision of supporting functions.
    • Enable interaction with a former MHRA inspector to understand the right approach to avoid regulatory impact.
    • Provide opportunities to engage with management from other pharmaceutical companies.
    • Highlight importance of management involvement in quality and compliance. 

    Programme Content and Key Areas

    Key topics:

    • Effective assessment of the RP
    • Outsourcing pros and cons
    • The Cost of Quality
    • Provision of the Quality Management System (QMS)
    • The benefits and disadvantages of an eQMS
    • Designing systems to reduce criticality
    • Jargon Buster
    • Inspection readiness
    • Discussions to embed learning

    Learning Outcomes

    Those attending will:

    • Gain a better understanding of the relevance and requirements of GDP and the Human Medicines Regulations.
    • Understand their role in using compliance as a business driver.
    • Develop sufficient knowledge to safely and effectively delegate decision making.
    • Have a greater understanding of licensing and inspection requirements.
    • Effectively deliberate key issues with other industry representatives.

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