Training on implementation and validation of CS according to GAMP 5

Day 1: theory

Validation means...
Validation principles
Standards and instruments (GMP, GLP, GDP, 21CFR11, PIC/S)
GAMP 5
Validation preparation
Customer Requirement Specification (URS)
Functional Requirements (FS)
Technical Requirements (TS)
Validation organization
Validation Master Plan (VMP)
Validation Plan (VP)
Risk Analysis (RA)
Supplier audit
Validation preparation (DQ, IQ, OQ, PQ)
Design Document Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Operational qualification (PQ1 and PQ2)
Running tests
Final stage of validation
Final Validation Report
Traceability Matrix
Validation of EXCEL tables
Maintaining the system in a validation state
Final stage of validation

Day 2: practice

Case study – validation of the DOCUMENT FLOW system with Electronic Signature
Case Study – SCADA System Validation

 

Reviews:

 

Lead Automation Engineer
I would like to first thank you for the seminar, the seminar turned out to be quite informative, I liked how easily, accurately and clearly you explain quite complex topics. I would especially like to note the responsiveness and attentiveness of the teachers. During the seminar, I gained tremendous experience and knowledge in just two days. Thank you for the quality of your work!

 

Validation Expert
On November 26 to 27,  a very amazing and informative seminar was held on the topic “Implementation and Validation of Computerized Systems (GAMP5).” First of all, I would like to thank Fabrice for organizing this seminar. A friendly atmosphere reigned in the audience, despite the fact that the participants were from all cities of Russia and even Kazakhstan. I came from the seminar with a huge amount of knowledge and impressions. I would like to further list the important aspects of the seminar that I was pleased with:

The lecturers who spoke were very qualified.
The presentations provided were professional and the training materials were acceptable.

Deputy Head of the Production Laboratory for Science
First of all, let me once again thank you and your colleagues for a wonderful seminar. I was pleased with both the volume and quality of the material. I would especially like to note the friendliness and openness to questions from listeners. In my opinion, this is very important when the seminar leader not only conveys the theory, but also shares real practical experience, which was demonstrated.

Head of Validation and Documentation Department
Once again I would like to thank you for the seminar on the implementation and validation of computerized systems. Thank you for the quality information provided. The topic of the seminar is very relevant and interesting. The seminar program was very intense. The seminar was held in an atmosphere of mutual understanding, lively communication and active exchange of experience. I would like to use the knowledge gained in my work.

Technological engineer 
I would like to thank you very much for the seminar, it was, firstly, very interesting, and secondly, very useful. It became clear what and how to do in order to validate computer systems, where to start, how and which specialists should develop and perform tests, and how to maintain the validation status of systems.

Leading Specialist of QA
Good afternoon, Fabrice! I would like to leave a review of your past learning. The training was very thorough, interesting, nice that I heard the answers to all my questions. My wish: specific recommendations for the compilation of URS (eg URS per page of Excel), protocols and reports on the qualifications of computer systems, drafting principles. I would like to receive information about education those employees who are entitled to make the above documents. Role of Quality Assurance Department in validation of CS.

Head of IT Department
I would like to thank you for a useful and interesting seminar on the validation of computerized systems. I had encountered tasks related to the validation of computerized systems in an enterprise before, but I did not have the theoretical basis to perform these tasks effectively.

Participation in the seminar allowed us to largely rethink the tasks completed and plan work to increase the fault tolerance of computerized systems through a more effective approach to validation. In addition, I had a clear picture in my head of the action plan for validating new computerized systems and planning resources for implementation projects.

It was extremely interesting and useful to learn the work experience of validation specialists from Europe. This is the most valuable information that I took into account. Additionally, I was able to communicate with colleagues who deal with the validation of computerized systems every day, to understand the general situation on this topic at pharmaceutical enterprises in our country.