9. Services
 9.1. Training 

Training is the starting point for any activity related to risk control under the IEC 61508 standard or the deployment of the GAMP. I am accredited as a training organization under number 11 91 06813 91. My sessions are designed with the following objectives in mind:

  • Compliance with ISA and ISPE educational requirements
  • Taking into account the feedback of the reality of the culture of automaticians in the field of safety
  • Compliance with the requirements of the ISO 29900 standard (training services)
  • Maximizing interaction between trainees and instructor

Sessions can be given inter and intra-company. Courses for a single company are usually tailored to the specific objectives of the company (often a project in progress) following a discussion and agreement. Training can be centered on a use case provided by the company.

I also offer these sessions as part of the French ISA sction.

I propose a complete range of courses to approach and then deepen the various fields concerned:

For everyone

  • One-day course for project managers focused on the specific aspects of automation projects and associated risk management

For the deployment of the GAMP

  • 2-day course for project managers and engineers presenting GAMP content and expectations of qualification / validation teams
  • 1-day course centered on electronic signatures (FDA 21CFR11)

 

For functional safety
  • Half-day session to sensitize managers and project leaders
  • 2 to 3 day introductory course for decision makers and project managers. This course provides an overview of the requirements of the repository in order to organize and structure a project by mobilizing the resources of the various departments concerned in the company.
  • 1-day quality assurance course for validation teams
  • 1-Day Course for Operators and Maintainers
  • One-day course for technicians and engineers responsible for availability calculations
  • One-day course on modeling techniques for technicians and engineers responsible for building the architectures of security systems
  • 1-day course in software and application development for programmers and project managers
  • 5-day course for security system programmers 1-day course focusing on the differences between IEC 61511 and IEC 61508