Webinar on FDA Compliance and Laboratory Computer System Validation
Website https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1828 |
Category Food, Drugs & Biologics
Deadline: July 27, 2106 | Date: July 27, 2106
Venue/Country: Online, Canada
Updated: 2016-06-30 18:47:08 (GMT+9)
Call For Papers - CFPThere is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.Areas Covered in the Session :Gain an understanding of laboratory system computer validation planning, execution and management conceptsDiscuss the best practices for laboratory computer system validation that will ensure compliant results while minimizing costsIdentify the GAMP 5 category for the system to understand how best to approach validation, particularly testingDiscuss the key documentation associated with validating laboratory systems and maintaining them in a validated state, while minimizing costsLearn how to leverage these practices across all systems by creating a standardized program for FDA-regulated systemsUnderstand the training that must be provided to business and IT staff involved in the validation processDiscuss the business process re-engineering opportunities that might be leveraged as a system is implemented, particularly if it is more advanced than the legacy system in terms of technology and functionalityLearn the advantage of incorporating a formal organizational change management system into the validation effort to ensure that users fully embrace the new technology and functionalityWho Will Benefit:This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Professionals who will benefit include:Information Technology AnalystsInformation Technology Developers and TestersQC/QA Managers and AnalystsAnalytical ChemistsCompliance and Audit ManagersLaboratory ManagersAutomation AnalystsComputer System Validation SpecialistsGMP Training SpecialistsBusiness Stakeholders/Subject Matter ExpertsBusiness System/Application TestersConsultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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