Online Webinar :Maintaining Compliance of FDA-Regulated Computer Systems
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Website http://c2gowebinars.com/product/?topic=maintaining-compliance-of-fdaregulated-computer-systems |
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Deadline: June 16, 2016 | Date: June 16, 2016
Venue/Country: Online, U.S.A
Updated: 2016-05-03 16:57:12 (GMT+9)
Call For Papers - CFP
DESCRIPTION"The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and have evolved over the last thirty years to align with changes in technology and best practices developed by industry, including the inclusion of risk assessment as a critical component of validation.Validation of computer systems in the regulatory environment must be a continuous rather than a discrete process. When auditing, regulatory agencies will expect you to have adequately planned and executed your computer system validation effort, and continue to maintain your system in a validated state."Why should you attend :Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.Applying best practices will ultimately result in minimizing the time and cost of regulatory audits, and the impact on operations and productivity. While there are many sources of information to help you develop a good validation program, this course will narrow down the most overall cost-effective approach that is tried and true.It is not enough just to validate a computer system and defend your approach to regulatory agencies. You will also need to ensure that the data and information collected, analyzed and reported using the system can be defended effectively, as well. In this course, you will learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies. At the same time, you will learn how to do this in the most cost-effective manner."Areas Covered in the Session:This seminar will help you understand in detail the System Development Life Cycle (SDLC) Methodology and the importance of following this approach when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do as functionality and other changes occur over time. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.Who will benefit: (Titles)Information Technology AnalystsInformation Technology Developers and TestersQC/QA Managers and AnalystsClinical Data Managers and ScientistsAnalytical ChemistsLaboratory ManagersAutomation AnalystsComputer System Validation SpecialistsGMP Training SpecialistsBusiness Stakeholders/Subject Matter ExpertsBusiness System/Application TestersThis webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.Webinar includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate of attendanceFor Registration : http://c2gowebinars.com/product/?topic=maintaining-compliance-of-fdaregulated-computer-systemsNote: Use coupon code and get 15% off on registration.
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