Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11: With Clear Recommendations for Corrective and Preventive Actions

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Overview:  The new Part 11 regulation takes quite some time, but inspectors go out and focus inspections on computer systems and electronic-records for compliance with GMPs. Just in 2007/2008, there have more than 20 deviations related to computer system validation and Part 11compliance, some with disastrous consequences for inspected companies.  Purchase this Web seminar CD and learn how to avoid such warning letters. You will learn: FDA inspections: Preparation, conducts, follow up The meaning of warning letters and 483 inspectional observations Learning from an FDA presentation: “Data Integrity and Fraud - Another Looming Crisis?” Data integrity: FDA's new focus during inspections of computer systems and e-records Examples of recent Part11 483’s and warning Letters Examples of recent 483’ and warning letters related to computer system validation  Most obvious reasons for deviations Responding to 483's to avoid warning letters Writing corrective and preventive action plans to avoid 483 The future of Part 11and computer system validation Who Should Purchase? IT managers and personnel Everybody responsible for FDA compliance of computer systems Managers from purchasing, documentation and operations All users of computer systems used in regulated environments QA managers and personnel GLP/GMP/GCP auditors Consultants Teachers

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