Overview: This interactive webinar provides an overview of techniques used for buying, deploying, validating, and maintaining computer systems used for clinical trials. Computer systems used in clinical trials manage enrollment, payments, and collection of subject data. These systems must be secure and highly reliable. Often IT, QA, and the users are too busy and inexperienced to implement and maintain a system on an ongoing basis. If you have a new system or an upgrade to install, this course will teach you how to reduce costs and implementation time; typically to one third. Use fill-in-the-blank templates for validation documentation. Learn how to identify risk and mitigate it thereby reducing testing time and resources. Avoid errors that results in 483s and warning letters. Understand the industry standards for required features related to security, data transfer, audit trails, and electronic signatures. Areas Covered in the Session: How to significantly lower costs and reduce software implementation time How to avoid 483s and warning letters Security and software requirements for electronic records and signatures Required features Who Will Benefit: All system users IT QA Managers Executives Software vendors David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects. AMAZINES.COM
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Online Training, Clinical Trials, avoid 483s, warning letters, deploying, validating, maintaining computer systems,
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