Topic outline

  • Pharmaceutical Legislation Update

    International pharmaceutical laws, regulations and guidance change at a frightening pace – it’s difficult to keep up!  That’s why we have developed this one-day “refresher” course for you.  We keep track of all the changes so you don’t have to – just come along and learn what’s new and what’s on the horizon.
    Course Code COM-049
    Region

    North West England, Yorkshire and Humber, Amsterdam, Netherlands
    Delivery Classroom, e-Learning
    Role Role: Other, Manager/Senior Manager, Supervisor
    Competence Compliance
    Sector Sector: Adhesive & Sealants, Anaerobic Digestion and Biogas, Asbestos, Chemicals, Coatings Paints and Resins, Composites, Downstream Petroleum, Education, Energy, Engineering, Fracking or Shale Gas, Healthcare (NHS), Industrial Biotechnology, Medical Biotechnology, Nuclear, Packaging, Personal Care & Consumer Products, Pharmaceuticals, Polymers, Requires investigating, Sector-wide, Signmaking, Water Treatment

    This Course is Aimed at

    Ideal CPD for the busy Qualified Person or pharmaceutical quality professional.

    • Quality Assurance personnel, in particular Qualified Persons
    • Other technical/managerial personnel responsible for the manufacture and testing of APIs and medicinal products

    Overview

    Pharmaceutical legislation and regulatory authority guidance is continually changing. These changes to legislation and guidelines, and the interpretation of them, can have significant implications for companies. Many changes require detailed planning to implement and failure to do so can result in serious compliance problems.

     

    This is the continuation of a very successful series of one-day seminars that are designed to form part of your CPD.

     

    This course is also Royal Society of Chemistry approved as suitable for their members’ CPD.

    Programme Content and Key Areas

    To understand and discuss the current interpretation of recently implemented and proposed changes to:

    • EU legislation: Directives and regulations
    • EU GMP: Chapters and annexes
    • The impacts of Brexit on biopharmaceutical processes and supply chains across the EU and the UK
    • ICH guidance
    • US legislation and FDA guidance
    • UK MHRA requirements and processes

    Learning Outcomes

    .....


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     01325 740900

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