ExL Pharmas Computer System Validation in the Pharmaceutical Industry Webinar (P430)
|Event Date/Time: Sep 17, 2009||End Date/Time: Sep 17, 2009|
* To ensure product quality and health of patients
* Gain confidence in data both internally and externally
* Comply with regulations
* Assure â€œInspection Readinessâ€
* Maximize benefit or your IT systems
Assessing your system
* Does the system need to be validated?
* Creating a validation plan
* What are the user requirements?
* What actions need to be taken if your system is outsourced?
* What type of validation is needed?
Take Away Information
* Recognize the importance of computer system validation
* Know what is required and â€œ recommendedâ€ by FDA, ICH, PIC/S and GAMP
* Assess your system and determine the need for validation
* Create and execute a validation plan
* How to effectively test and qualify your system to maintain validated status
* Understanding of the risks involved with computer systems
* Classification of projects/documents/systems to avoid redundancy
* Identify who should be involved with the computer system validation and how to train them
* Effective implementation strategies