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| Begins |
September 17, 2009
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| Category |
Health: Pharmacy
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| Contact |
555 8th Avenue
Suite 310
New York, NY 10018
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| Description |
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
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| 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
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