Why validate your computer system?

* To ensure product quality and health of patients
* Gain confidence in data both internally and externally
* Comply with regulations
* Assure “Inspection Readiness”
* 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 “ recommended” 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

Who should Attend This webinar is of interest to those in the pharmaceutical, biotech and medical device industries with responsibilities in the following areas: * Systems Validation * Information Technology * Quality Assurance * Data Management * Regulatory Affairs * Scientific Affairs * Software Quality Engineering