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This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures. Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. interview skills englishElectronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. Learning Objectives: – Learn about the regulatory background and requirements for equipment qualification according to USP and computer system validation according to GAMP Guides – Be able to explain the difference between equipment calibration, qualification and system validation – Learn which equipment/systems need to be qualified or validated – Be able to allocate equipment and systems to USP and GAMP categories and to design and execute qualification/validation protocols accordingly – Understand the logic and principles of instrument qualification and system validation from planning to reporting – Be able to explain your company’s qualification and validation strategies – Understand how to archive raw data from hybrid systems: electronic vs. paper – Be able to define and demonstrate Part 11 compliance functionality to auditors and inspectors – Be able to develop inspection ready documentation during on-going routine operation – Learn how to ensure, document and audit integrity of raw data and other records For more information about this conference visit http://www.researchandmarkets.com/research/x2mmhp/analytical Contacts
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The only requirement to run for the seat is residency in the First Ward, which covers the northwest section of the city. http://www.theactproject.com/wwwtheactprojectcom8818/2017/01/15/obtaining-the-answers-for-recognising-important-issues-of-application-form-for-nhs/Nestic served as president pro tem, which meant he ran the meetings in the absence of the council president. By virtue of being president pro tem, that also made him the chairman of the Committee of the Whole, which encompasses all seven council members. He also chaired the Economic Development Committee and was a member of the Finance and Utilities committees. He was councils representative to the Salem Area Industrial Development Corporation and made it his mission to push for economic development in the city. During his tenure, the Sustainable Opportunity Development Center was formed and started working on economic development activities on the citys behalf. As a technology commercialization consultant, he owns and operates NezTech Corporation and also owns a building in downtown Salem and some vacant property. City council meets at 7 p.m. Tuesday to reorganize for the year, followed by a regular council session. Apple said he still plans on announcing his new council committee assignments, leaving blank spaces for the new council member.
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