ISO Standards

GAMP®5 Awareness Training Course

Compliance Control Ltd. will be hosting a GAMP®5 Awareness Training Course on Tuesday 15th Dec 2015.

The course is designed to help businesses understand how using ISPE GAMP®5 guide can help ensure that their Computer Systems and underlying IT infrastructure are compliant and inspection ready. The course will also cover the full Computer System Validation life cycle, including Validation Planning and Reporting, development of User Requirement Specifications, Functional Specifications, Test Specifications, Risk Assessments etc.

The course will also cover a wide range of Computer Systems ranging from medical devices and mobile devices to Laboratories, ERP and Electronic Quality and Document Management Systems, including IT Infrastructure Qualification.

ISO 9001, 27001 and 13485 will also be discussed and for companies looking to write software for medical devices, purchase bespoke software (SOUP) or devices containing bespoke software, the implications of IEC 62304 will be discussed.

This event will be hosted by David Forrest, Chief Executive of Compliance Control. 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.

To find out more information about this event click here.


     
     

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

 

 

    

 



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