This training is specially designed for Automation Engineers and Validation Engineers who want to modernize and optimize their validation approach.
The following topics are covered:
- Digital validation tools
- Directives and legislation, EU and FDA (also annex 11, 15 and 21 CFR part 11)
- Process and Data Flow
- GAMP®5; the Commissioning Qualification Validation Life Cycle
- Drafting User Requirements Specification (URS)
- Software development - software categories
- Functional, Configuration and Design Specification, Design Review/Qualification (DR/DQ)
- Risk Management
- The training works with Microsoft Azure DevOps; It is necessary to bring a laptop for training.
For whom
This training is especially intended for Commissioning Qualification Validation (CQV) employees, quality assurance officers, engineers, IT professionals and other interested parties who come into contact with CQV of systems according to GAMP®5. Some knowledge of validation and GAMP®5 is recommended to be able to follow this training properly.
If non-Dutch-speaking students participate, the training will be given in English.
General information
- The participant will receive an email with the location details 2 weeks before the training
- The participant receives a certificate after the training
- Lunch and drinks during training are included
- At the beginning of the training, the participant receives a training folder containing the printed slides of the presentation.
Trainers
Price
€ 895.00 per participant (excl. VAT)
Data
You can register via our training overview
For information, please contact René van Opstal on +31 (0) 6 53 63 06 98 or email info@PQTInternational.com