Webinar on How to Detect Lack of Data Integrity
Website https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB2031 |
Category Food, Drugs & Biologics
Deadline: July 27, 2106 | Date: July 27, 2106
Venue/Country: Online, Canada
Updated: 2016-06-30 18:50:11 (GMT+9)
Call For Papers - CFPDescription : Data are central to the development, manufacture and marketing of pharmaceuticals of all types. The renewed interest in data integrity raises questions regarding what is data integrity and how to assess it. Lack of data integrity comes in two forms: purposeful manipulation of the data to deceive and the inadvertent problems that occur in the production and analysis of data. Humans, equipment or both can be the source of the problem. This session discusses both types of data integrity sources and introduces the assessment of “data pedigree” as a concept that puts focus on the types of data integrity issues and analytical and statistical methods for detecting data problems. Pharma and biotech case studies are used throughout the presentation to illustrate how the various approaches together.Areas Covered in the Session :What is data integrity; what does it look likeCase studies illustrating types and sources of data integrity issuesProcedures for assessing data pedigree, integrity and qualityComputer, analytical and statistical methods for evaluating data integrity and qualityLimitations of observational dataGuiding principles, tips and traps for the effective data integrity assessmentWho Will Benefit:Senior managementQuality Assurance Team MembersQuality Control Team MembersCompliance AuditorsProcess Development Team MembersSupply Chain and Logistics ManagersRegulatory Affairs Team MembersEngineering StaffIT Management and Staff working in regulated areas
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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