Computer Systems Validation
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Website http://bit.ly/2ERV78N |
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Category Understanding of Computer System Validation, CSV Training
Deadline: March 20, 2018 | Date: March 20, 2018
Venue/Country: Training Doyens 26468 E Walker Dr,Aurora, Colora, U.S.A
Updated: 2018-02-21 13:49:41 (GMT+9)
Call For Papers - CFP
OVERVIEWThis will cover the history of Computer Systems Validation in the Pharmaceutical and Medical Device industries. This led to the regulation 21 CFR Part 11, which covers the management of both electronic signatures and electronic records.Compliance to relevant regulations using Standard Operating Procedures and required documentation will be covered. The roles of Audits, Quality Assurance, and Risk Management will also be covered.WHY SHOULD YOU ATTENDChanges continue to be implemented in many existing computer systems and in many cases computer systems are being replaced or upgraded using new technologies. Many of these changes require Validation and Validation typically involves almost everyone who uses or supports the systems.Doing Validation is a “Project” that requires participation of many of those involved in the system. Some of this involves strong management commitment to the accuracy and quality of the products of the systems.AREAS COVEREDHistory of Validation RegulationsSome CSV Standards to useStandard Operating ProceduresNecessary DocumentationLEARNING OBJECTIVESUnderstand Computer Systems ValidationCover The role of Electronic RecordsLearn the Compliance to 21 CFR Part 11The role of Qualification in ValidationPreparation of Standard Operating ProceduresThe Documentation needed for ValidationWHO WILL BENEFITIT StaffComputer System UsersQuality AssuranceRegulatorySystem VendorsSPEAKERRichard Chamberlain's experience includes consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation. He has also managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.For more details click on this link:http://bit.ly/2ERV78NYou may also refer to this link:https://www.trainingdoyens.com/product/50169-oos-oot-investigation https://www.trainingdoyens.com/product/50175-capa-training-webinarhttps://www.trainingdoyens.com/product/50213-csv-training
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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