10times
Conference

Data Integrity: FDA/EU Requirements and Implementation

14 - 15 Sep 2020

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Data Integrity: FDA/EU Requirements and Implementation 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.


Timings

Starts at 10:00 AM GMT-4:00

Entry Fees

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Participants

upto 100
Delegates
Based on previous editions

Category & Type

Conference
Medical & Pharma

Editions

14 - 15 Sep 2020 Interested
09 - 10 Jul 2020
18 - 19 Jun 2020
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Frequency Quarterly

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Different Located Editions
Copenhagen, Denmark 18 - 19 Jun 2020
San Diego, USA 26 - 27 Mar 2020
London, UK 12 - 13 Dec 2019
2 Followers
Zürich, Switzerland 27 - 28 Sep 2017
11 Followers
Burlingame, USA 13 - 14 Feb 2017
2 Followers

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