GAMP®5 Training Courses

Why do you need GAMP®5 knowledge?

The updated regulation, “EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 11: Computerised Systems”  came into operation on 30th June 2011.

This annex applies to all forms of computerised systems used as part of GMP regulated activity. A computerised system is a set of software and hardware components which together fulfil certain functionalities. The regulation states “The application should be validated; IT infrastructure should be qualified”

Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.

Why choose Compliance Control?

We are GAMP®5 experts and with over 25 years’ experience delivering corporate compliance, Compliance Control understands the need to enhance quality and increase efficiency and is able to offer affordable solutions, tailor made to your business requirements, fully compliant and validated.

What do our courses give you?

Attending our courses will help you understand the regulation and how using GAMP can help you to ensure your Computer Systems and underlying IT infrastructure are always inspection ready. 

The course includes:

  • Computer System Validation as detailed in the ISPE GAMP®5 guide
  • Validation Planning and Reporting
  • Complete Computer Systems Validation life cycle
  • We cover a wide range of Computer Systems ranging from equipment, to Laboratories, to ERP and IT Infrastructure Qualification 
  • Use of Electronic Records and Electronic Signatures 
  • ISO 9001, 13485 and Medical Device International Standard 62304
  • Implementation and Management of a Quality Management system
  • Document Management, Change Management, Corrective Action and Preventative Action (CAPA), Deviations, Complaints, Audits, and Training Records
  • Introduction of an electronic system, showing how Computer System Validation, and IT Systems and Equipment can be effectively managed through an electronic system.

Our GAMP training courses are very popular so contact us as early as possible to avoid disappointment 

 


     
     

Customer References

  • I can certainly recommend Compliance Control as experts in this field and they will add value and deliver on your project. CFO, Major Pharma Company
  • Compliance Controls Consultants brought immediate expertise to our team as part of our drive into the European market. Vice President, Research & Development, Pharma Company
  • We wanted an organization with proven experience ensuring our organization can meet EU regulatory requirements. Business Development Manager, Phama Company
  • I would like to personally express my great appreciation for all your excellent work and great support with the validation of our IT infrastructure and software. Managing Director, Compounding Centre, UK
  • ComplianceControl Centre was selected because it is easy to use, quick to set up, and was a validated, cost effective solution for an organization of our size. We wanted a system that we could rapidly implement. Vice President, Research & Development, Pharma Company
  • Working with Compliance Control Consultants and their software products ComplianceControl Centre and cGARD helped us to understand the regulatory requirements of IT and business systems more clearly. IT Director, Pharma company
  • Using ComplianceControl Centre will help us to ensure that we are always inspection ready, by tracking our critical Quality and Compliance activities. Vice President, Research & Development, Pharma Company
  • It has been a pleasure working with you and your team and I am looking forward to co-operating with your company on similar projects in the future. Managing Director Compounding Centre UK
  • Based on your achievements and delivered results, we have started the process of building up our internal team for continuation of the work started by you. Managing Director, Pharma Company
  • cGARD has become the new rage here ! Sr. Manager, Documentation and Training, Major Pharma Company

 

 

    

 



© Compliance Control 2014