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2020 - Data Integrity: FDA/EU Requirements and Implementation

Date2020-07-09 - 2020-07-10

Deadline2020-06-29

VenueVirtual Seminar, USA - United States USA - United States

KeywordsData integrity workshop; Gxp regulations; Fda part 11

Websitehttps://www.complianceonline.com/data-in...

Topics/Call fo Papers

This 2-day on-line course explains the background to the data integrity regulations and sets out the expectations of pharmaceutical regulators. All the current data integrity guidances emphasise a risk-based approach to compliance, and the course explains how to evaluate and control data integrity risks. A key resource in relation to electronic records is GAMP 5, which deals with controlling risk and managing computerised systems over their life cycle. The practices recommended by GAMP 5 will be dealt with in detail, and practical advice on the appropriate use of Excel spreadsheets given. Data integrity should not be thought of as an exclusively analytical problem, and examples of data integrity violations in production will highlight the risks during manufacturing.

Last modified: 2020-06-23 02:59:16