ExL Pharmas Computer System Validation in the Pharmaceutical Industry Webinar (P430)

Venue: Webinar

Location: Webinar, Webinar, United States

Event Date/Time: Sep 17, 2009 End Date/Time: Sep 17, 2009
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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


United States

Additional Information

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