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GMP, GAMP® & Validation Training > GAMP® Training > GAMP® 5 (3 Day) Training

GAMP® 5 (3 Day) Training

Course Title:GAMP® 5 (3 Day) Training
Course Delivery:

The GAMP® 5 (3 Day) Training Course can be delivered in a hotel, one of our offices, your premises or online via a virtual classroom. The course content can be tailored to meet your requirements. Request a quote for an onsite or online virtual course for an agreed number of delegates from your site.

Course Duration:3 days
Course Overview:

Keeping current with the latest regulatory requirements and industry guidance can be a challenge when you have a hundred and one tasks to complete.

The GAMP® 5 (3 Day) Training goes beyond our Fundamentals of GAMP® 5 Guidance by investigating in depth the main topics in the latest version of GAMP® 5: A Risk-Based Approach to Compliant GxP Computerised Systems, and reviewing sample appendices from the following sections: Development, Management, Operation and Special Interest Topics.

Taking the opportunity to attend this course is useful for people working in healthcare manufacturing and related IT departments. Suppliers can also benefit. National Blood Service employees and other industries such as bank ATM manufacturers have also attended this course.

So if you want a full working understanding of current regulatory thinking on computerised systems in industry, for IT, process control systems and manufacturing/packaging equipment, why not attend our course?

Course Content:

Day 1

  • Investigate the reasons for the GAMP® 5 version update
    • Industry developments
    • Regulatory drive including Quality Risk Management, ICH Guidance and integration into QMS
    • Latest terminology and common themes including relationship between Qualification Terminology and GAMP® 5 activities
  • Compare the differences between GAMP® 4 and GAMP® 5
    • Cross referenced table of differences
    • Look at key concepts
    • Main article and contents
    • Appendices
  • Review the life cycle approach and phases, including: life cycle concepts; concept, project and retirement
    • Project
      • planning
      • specification
      • configuration and coding
      • verification
      • reporting and release
      • support
    • To include practical examples based upon GAMP® categories of software
    • Operational phases including
      • Handover
      • CAPA
      • Change management
      • Security and system administration
  • Introducing Quality Risk Management
    • An overview of Quality Risk Management including:
      • Integration to the QMS
      • The process itself and links to ICH Q9
  • Describe regulated company activities to assure computerised system compliance
    • Elements to achieve compliance
      • Policies and procedures, roles and responsibilities
      • Training, managing supplier relationships, system inventories and specific activities
  • Develop understanding of guidance on supplier activities
    • View help for suppliers; non configured product, configured product and custom package
    • Investigate supplier best practices

Day 2

  • Consider guidance on efficiency improvements
    • Specific points in determining objective user requirements
    • Utilise risk assessment practice to determine life cycle activities
    • Influence supplier input and maximise use of own documentation
    • Effective testing and system handover
    • Operational activities
  • Review main article topic 4, Life Cycle Phases, related Management Appendices
    • M1 Validation Planning
    • M2 Supplier Assessment
    • M4 Categories of Software and Hardware
    • M5 Design Review and Traceability
    • M7 Validation Reporting
    • Investigate changes to appendices and also new management appendix M10
  • View appendix M3 Science Based Quality Risk Management relative to article 4 and 5 in the main contents of the guide
    • Roles and responsibilities
    • Guidance and examples for different categories of systems

Day 3

  • Research remaining appendices
    • D2 Functional Specification
    • D3 Configuration and Design
    • D4 Incident Management
    • D5 Testing relative to article 4
  • Check revised appendices and new appendices
    • D6 System Description
    • D7 Data Migration
  • Develop understanding of new Operational Appendices covering
    • O1 Handover
    • O4 Incident Management
    • O5 CAPA
    • O7 Repair Activity
    • O12 System Administration
  • Investigate the special interest topics appendices
    • S1 Alignment of ASTM E2500
    • S2 Electronic Production Records
    • S3 End User Applications
    • S4 Patch Management
    • S5 Managing Quality within an outsourced IS/IT environment
    • S6 Organisational Change
  • Review of G1 GAMP® Good Practice Guides

    Open Course Dates:
    GAMP® 5 (3 Day) Training Course
    20 April 2021 - 22 April 2021, Online Virtual Classroom Delivery, £1575+VAT per learner.
    GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance
    20 April 2021, Online Virtual Classroom Delivery, £577+VAT per learner.
    GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance
    22 June 2021, Online Virtual Classroom Delivery, £577+VAT per learner.
    GAMP® 5 (3 Day) Training Course
    22 June 2021 - 24 June 2021, Online Virtual Classroom Delivery, £1575+VAT per learner.
    GAMP® 5 (3 Day) Training Course
    21 September 2021 - 23 September 2021, Near Manchester Airport, £1575+VAT per learner.
    GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance
    21 September 2021, Near Manchester Airport, £577+VAT per learner.
    GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance
    23 November 2021, Newcastle, £577+VAT per learner.
    GAMP® 5 (3 Day) Training Course
    23 November 2021 - 25 November 2021, Newcastle, £1575+VAT per learner.

    GROUP BOOKING DISCOUNT - Book more than one place on an open course and receive the following discounts:

    • 10% discount on second place
    • 20% discount on third place
    • 25% discount on fourth place

    Group booking discounts cannot be used in conjunction with any other offer.

    Cost includes tuition, lunch and training materials. Download a printable version of the Booking Form and Terms and Conditions.

    Onsite Courses:

    This course can be delivered to a group of up to 12 delegates at your premises or as an online virtual classroom course for an agreed number of delegates from your site. Request a quote.


    “An excellent overview of the GAMP® guide and its structure and content.”

    “Very enjoyable and informative.“
    The Co-Operative Pharmacy

    “Easy to follow with clear notes provided.”
    Bio Products Laboratory Ltd

    “Very good training. Enjoyed the small setting which allowed for lots of questions.”
    London School of Hygiene & Tropical Medicine

    “I found the course to be thoroughly interesting. I learnt a great deal and the trainer, Alan was very knowledgeable. I would definitely recommend this course.”
    Cooper Vision

    “Excellent course. It was very informative and easy to apply to my current role.”

    “It was very informative, well explained and applied to practical examples.”

    “Very good course, well presented with mix of media and experienced trainer. Good extra resources recommended.”

    “Very good knowledge trainer.”

    “The course has been tailored to my specific needs. I can now progress to the next update of the company validation approach.”
    Open course delegate

    “Clear and in-depth.”
    Jenson R+

    “Very useful.”
    Jenson R+

    “Good overview of GAMP® 5.”
    Bioquell UK Ltd

    “Well structured and delivered in easy to understand terms.”
    Anritsu Industrial Solutions

    “Worthwhile to attend.”
    ABB Ltd

    “Comprehensive and informative”
    Selo UK Ltd

    “I’m very satisfied with the course. Thank you! Along with the amazing venue, I really got all I needed from this.”
    Orion Oyj

    “Very helpful.”

    “The trainer supplied was experienced and knowledgeable in the subject.”
    Pall Europe Limited

    “In-depth handouts and flexible training.”
    Pall Europe Limited

    “Good course pace and learning materials.”
    Pall Europe Limited

    “Detailed and friendly.”
    Novartis Grimsby Ltd

    “Very informative.”
    Novartis Grimsby Ltd

    ITS Tutor's Experience:

    ITS’ Regulatory Compliance Trainer, Dr Jennifer Thompson, has over 20 years of experience in the pharmaceutical sector in computer systems validation and IT infrastructure controls and compliance and has delivered projects for a wide range of companies in the UK, EU and USA including GlaxoSmithKline, Novartis Healthcare, Lonza Biologics, Elan Pharmaceuticals, Hoffman LaRoche and others. Her experience covers computerised systems used in manufacturing, laboratories, enterprise systems and clinical trials management. She has written articles and given presentations on a wide range of topics and contributed to the GAMP® Good Practice Guide “A Risk-based Approach to GxP Process Control Systems” and “The Risk Based Compliance Handbook” by Siegfried Schmitt (Paraxel).


    Further Information:
    Request more information on this training course.

    Course Calendar:


    Contact our team today

    For further information, please contact
    our team on +44 (0)1642 222232 or