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GAMP® Training


  • GAMP® 5 (3 Day) Training

    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?


  • GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance

    Keeping current with the latest regulatory requirements and industry guidance can be a challenge when you have a hundred and one tasks to complete, but you can achieve it by taking just one day out of your working schedule to attend this catch-up course.

    It will help unravel the main topics in the latest version of GAMP® 5: A Risk-Based Approach to Compliant GxP Computerised Systems, and help refresh existing knowledge and practice.

    The GAMP® 5 course is ideal for those working in healthcare manufacturing and related IT departments, as well as suppliers.  People employed in the National Blood Service and other industries such as bank ATM manufacturers, have also attended and benefited from this course.


  • GAMP® 5 and Regulatory Records Requirements Training

    Keeping current with the latest regulatory requirements and industry guidance can be a challenge when you have a hundred and one tasks to complete.
    Over the first two days of the 3-day GAMP® 5 and Regulatory Records Requirements Training course, an overview is provided of the latest version of GAMP® 5: A Risk-Based Approach to Compliant GxP Computerised Systems.

    The following day provides an insight into the American regulation for Electronic Records and Signatures 21CFR Part 11, and an important update on the now effective revised EU Annex 11 guidance. During a review of the regulation and guidance, links are discussed to GAMP® 5 and its corresponding good practice guide on electronic records and signatures. 

    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 similar courses.

    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?


  • IT Infrastructure Control and Compliance Training

    Healthcare regulated companies are increasingly reliant on computerised systems for day-to-day activities and their validated status is contingent on the underlying combination of platforms and services that comprise the IT Infrastructure.

    The effective control of a company’s IT infrastructure can at best give measurable business benefits and at worst bring a company to a standstill while a problem is resolved.

    Are you aware of the regulatory requirements for the implementation and maintenance of a compliant IT infrastructure? Would you like to understand acknowledged good IT practices to improve your company’s regulatory conformance and business effectiveness?

    The IT Infrastructure Control and Compliance (1 Day) Training will provide you with an understanding of essential elements of an IT infrastructure including requirements for qualification and implementing good management practices, for maintaining effective compliance in a regulated healthcare company. The course also covers the subjects of quality risk management and outsourcing in a regulated IT environment.


  • GxP Compliant Laboratory Computerised Systems Training Course

    Automation of laboratory operations through the use of diverse and sophisticated technologies is increasing the challenges for regulated Healthcare companies to maintain compliant, efficient and effective systems.

    The successful control of laboratory computerised systems can at best offer a range of benefits including reduced downtime and maintenance costs and at worst leave a company with unacceptable expense with time overruns and risk of non-compliance.

    Are you aware of current regulatory requirements for the implementation and maintenance of compliant laboratory computerised systems? Would you like to understand acknowledged good laboratory automation practices to improve your company’s data integrity and regulatory conformance?

    The GxP Compliant Laboratory Computerised Systems (1 Day) Training Course is applicable to pharmaceutical, biological, medical device manufacturers and suppliers and will provide you with an understanding for implementing a rational, flexible approach to achieve greater efficiency and productivity aligned with focus on data integrity, product quality and patient safety. Subject matters covered include: