|
|
|
|
|
|
|
|
|
|
|
|
|
Computer Validation
3, 4 and 5 December 2008
Heidelberg, Germany
Please click here to view the program of this conference or course
To book for this program, just click on the option:
| |  |
At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
| |
Background
Computerised systems are a central factor determining work sequences in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention. This creates the requirement and necessity, however, to validate all computerised systems which can influence the quality of pharmaceutical products.
The basis of the education course will be the current requirements for the validation of computerised systems like GAMP and their GxP-oriented application in practice.
Experts from the pharmaceutical industry and from the GAMP Committee will show you efficient ways to validate your computerised systems.
Learning Objectives
This is why you should attend this course:
- You will systematically be introduced to the principles and methods of the validation of computerised systems (according to GAMP 4)
- You will learn the skills to plan, implement and document effectively validation activities for computerised systems and to assess them with respect to their GxP vcompliance
- You have the opportunity to practically apply the theoretical foundations in 7 workshops
PROGRAMME:
- Laws, Regulations and Guidelines for Computer Validation
- The GAMP 4 Approach / The Computer Validation Life Cycle
- An Introduction to Risk Management (including ICH Q9)
- Risk Assessment the GAMP Way
- Electronic Records and Signatures
- Auditing Suppliers
- Validation Planning
- Protocols and Testing
- Validation Documentation
- Change Control
- Validation Reporting & Presentation to Inspectors
- Introduction to IT-Infrastructure
- Qualification
- Regulatory Comments |
|
|
|
|
|
|
|
