FDA Issues and its FDA Data Integrity - 2017
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Website http://www.compliance4all.com/control/w_product/~product_id=501432LIVE?channel=ourglocal_Sep_2017_SE |
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Category Data Integrity, Manufacturing, FDA Webinars, data integrity in pharma, why is data integrity important, Compliance trainings, FDA manufacturing data integrity, data integrity issues, pharmaceutical data integrity, 2017 Webinars, Compliance data Management
Deadline: August 31, 2017 | Date: September 01, 2017
Venue/Country: Fremont, U.S.A
Updated: 2017-07-17 15:52:45 (GMT+9)
Call For Papers - CFP
Overview:Many of the data integrity issues that plagued the US drug and biologics industry were eliminated by detailed regulations and stricter enforcement, but many of the problems have resurfaced in recent years among the multitude of foreign manufacturers whoare not familiar with US practices.Areas Covered in the Session:Important Regulations related to Data Integrity, including laws related to the effects of bad dataGuidance Documents related to Data IntegrityRequirements for Computerized Instrument OutputsDefinition of Data Integrity TermsImportance of Audit TrailsExamples of Violations 483s taken from Warning LettersWho Will Benefit:Quality Control and Quality Assurance WorkersRegulatory Affairs PersonnelProduct Development WorkersPersonnel Planning Clinical StudiesManufacturing SupervisorsSpeaker Profile:Steven S. Kuwahara , Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.Event Cost & Details: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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