Which data and systems are subject to Part 11
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Website http://www.compliance4all.com/control/w_product/~product_id=501619LIVE?channel=ourglocal_Jan_2018_SE |
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Category Electronic Records, electronic records management system, 21 CFR Part 11, Compliance healthcare records, Electronic Records software, electronic healthcare records
Deadline: January 15, 2018 | Date: January 16, 2018
Venue/Country: Online, U.S.A
Updated: 2017-11-29 15:27:05 (GMT+9)
Call For Papers - CFP
Overview: This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach.Areas Covered in the Session:Which data and systems are subject to Part 11What Part 11 means to you, not just what it says in the regulationAvoid 483 and Warning LettersExplore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentationEnsure data integrity, security, and protect intellectual propertyWho Will Benefit:ITQAQCLaboratory StaffManagersGMP, GCP, GLP ProfessionalsSpeaker Profile:Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years.Event Fee: One Dial-in One Attendee Price: US$150.00Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: supportcompliance4All.com
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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