Topic outline

  • Pharmaceutical GMP

    This intensive and highly interactive three-day course is designed to teach you all you need to know about the latest EU requirements for Pharmaceutical GMP, so that you can go back to your workplace and put them into practice with your colleagues.


    Course Code COM-048
    Region

    North West England, Amsterdam, Hamburg

    Delivery Classroom
    Role Role: Engineer, Laboratory, Operator, Other, Manager/Senior Manager, Supervisor, Technician, All-roles
    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

    • Those new to the pharmaceutical industry
    • Experienced member of staff changing roles to work in a GMP environment
    • Those looking for a ‘refresher’ on pharmaceutical GMP

    Overview

    Whether you’re just starting out in the industry or you’re an experienced member of staff changing roles to work in a GMP environment, this course will provide you with the fundamentals and latest updates regarding GMP.

     

    This course covers key sections of the ever-changing EudraLex Volume 4 to provide a thorough understanding of the essentials of GMP.

     

    Why choose NSF for your pharmaceutical GMP training?

    • Tutors with real credibility and experience to bring GMP to life with examples and real-life stories
    • Training designed to reach all learning styles and preferences
    • Fantastic detailed reference material to take away and to become instantly useful
    • Bring your questions and have the free consultancy of tapping into great experience from helpful tutors
    • This course now forms an entry level GMP training requirement for our very popular Pharmaceutical Quality Systems Auditor/Lead Auditor Training Programme
    • An ideal starting point for our modular QP training program

    Programme Content and Key Areas

    • Why we have pharmaceutical good manufacturing practices
    • EudraLex Volume 4
    • Structure
    • Content
    • Application


    A copy of EudraLex Volume 4 is provided and is used as the basis of this course.

    • Appreciation of what is important for patients
    • Developing safe medicines and where GMP fits in the lifecycle of a medicinal product
    • An understanding of global GMP and licensing requirements
    • ICH Q9: Quality Risk Management
    • Responsibility of management
    • Supplier assurance and oversight of supply chains
    • Facility design considerations
    • Key utilities such as water and HVAC
    • Validation, calibration and maintenance
    • Operating an effective PQS including taking a closer look at human error, deviations, change control and complaints
    • People and the importance of training and understanding
    • Good documentation design principles
    • Importance of packaging
    • Data integrity
    • Laboratory controls
    • Audits and self-inspections
    • Good distribution practices


    Also includes:

    • Up-to-the-minute information on new pharmaceutical GMP initiatives and regulations
      • Key Changes Global GMP regulations
    • Practical advice on dealing with the difficult areas of pharmaceutical GMP
    • Access to experts for opinion on your GMP concerns

    Learning Outcomes

    On completion of this course delegates will know and understand:

    • The origin and reasons for GMP legislation
    • Key EU, UK and US GMP legislation
    • The practical interpretation of GMP expectations and best practices
    • EudraLex and PIC/S expectations
    • Premises, processes, products, procedures, people and GMP


    To book now contact us.

       

    Contact Us

     01325 740900

     Send us an enquiry


    Providers

    Click here to view our assured providers