Online Webinar :Medical Device Industry Trends for Computer Systems Regulated by FDA
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Deadline: June 23, 2016 | Date: June 23, 2016
Venue/Country: Online, U.S.A
Updated: 2016-05-05 19:11:32 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThe 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 :"The Webinar will focus on the importance of managing FDA oversight of computer system validation in the medical device industry by anticipating and preparing for trends. The type and extent of oversight varies with changes to the economic, political, and business environment. FDA funding, the length of government reach into the private sector, and the ability of companies to lobby the government for less regulation all play a role in terms of the dynamics at play between industry and the FDA.Medical device companies must be vigilant in understanding the factors that impact their ability to operate with oversight from FDA as it relates to computer system validation. In all cases, companies should do the right thing and have robust computer system validation programs that are well executed and documented. However, there are some extremes in oversight that occasionally crop up and may cause expectations to go above and beyond what is considered reasonable. In such cases, companies must determine how much risk to take in terms of the strength of their programs, and how well they are able to negotiate with their FDA auditors.Typically, a medical device company will develop a relationship with the FDA office that sends auditors to oversee computer system validation programs in their organization. Depending on upcoming trends, medical device companies may want to work harder to further strengthen these relationships and build greater trust with FDA to ensure that even as oversight becomes more overbearing, it will not cause the company to waste resources trying to meet expectations that may be unrealistic."A good example of a recent trend is the focus on risk management in developing, executing and documenting a validation program and validation plans for specific systems at medical device companies. FDA has fewer resources to conduct audits and oversight of computer system validation, hence medical device companies have been expected to identify the risk associated with each computer system that “touches” a medical device product (through manufacturing, testing, distribution, etc.), and take the appropriate measures to mitigate that risk. The trend has been for FDA to ask questions relevant to risk and ascertain fairly early during an audit what lengths the medical device company has gone to in order to prove they have thoroughly validated their systems accordingly.Areas Covered in the Session:Describe some of the key factors that influence the degree of FDA oversight for computer system validation programs in the medical device industryDiscuss how to anticipate and understand trends in FDA oversight of the medical device industry, as they begin to emergeDiscuss ways for medical device companies to build a solid relationship with FDA and leverage it to gather information about emerging trendsDiscuss ways that medical device companies can adjust their computer system validation programs to changes in the regulatory environmentDiscuss ways to apply basic computer system validation principles to ensure that in all cases a medical device company is prepared for emerging trendsProvide examples of changes to the factors influencing the regulatory environment and how medical device companies have reacted or respondedDiscuss some of the unnecessary risks medical device companies have taken in response to changes in the regulatory environment and the ramificationsQ&AWho 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=medical-device-industry-trends-for-computer-systems-regulated-by-fdaNote: Use coupon code and get 15% off on registration.
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