Validation procedures: COM&TEC course, spokesman Fabio Farneti, SPAI Ceo
The training and refresher course “Validation procedures. Analysis, drafting, management”, organised by COM&TEC (Italian Association for Technical Communication), which will have as its speaker Fabio Giovanni Farneti, CEO Spai, will take place online on 25th March and 1st April 2022.
The aim of the course is to provide an overview of the essential and procedural aspects of validation.
When and why perform the validation? It is necessary to perform the validation to comply with the requirements related to:
- Ensuring product quality
- Increased performance of the production process
- Legislative obligations.
The course outlines the fundamental aspects of the analysis required to perform validation, and the drafting and management of the specific documentation required. It provides the necessary elements for defining the areas in which validation is most applicable and illustrates the approach and methodology for risk analysis as a fundamental step in carrying out validation in an appropriate and objective manner. Finally, it shows and analyses the reference documents, the standards to refer to in validation, and examines some of the common errors in writing specification and test documents.
The programme
- Why validate
- Areas of application
- Types of validation
- Validation procedures
- Quality risk management approach
- GAMP5
- Validation documents and types
- Document contents
- Methods and critical issues related to the drafting of documents
Target audience
Communicators and Technical Editors, HMI Designers, Translators, Analysts and Validation Editors.
Date and modalities of partecipation
The course will take place on 25th March and 1st April from 9:30 to 12:30.
The total duration of the training course is 6 hours.
The training will take place online on the Zoom platform.
COM&TEC Coordination will send the access data to the email addresses indicated at the time of registration.
