ECA - Data Integrity

Art-No.: A-1114
Date: 13-15 March 2019

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
13707Why is Data Integrity Important? - Setting the Scene028
13708Data Integrity - EU GMP Requirements054
13709Principles of Data Integrity036
13710Facilitated Discussion / Workshop on Key Data Integrity Topics010
13711WHO / MHRA / FDA and GAMP5 Data Integrity Guidance Key Points032
13712Role of Management in Data Integrity018
13713Development and Scope of a Data Governance System018
13714Implementing Data Integrity Training022
13715Workshop: Analysis of an FDA Warning Letter06
13719US 21 CFR 211 and EU GMP Chapter 4: Complete data vs raw data vs primary record016
13720The PICS Guide PI 041 Good practices for data management and integrity in regulated GMP/GDP environments048
13721Ensuring Data Integrity in a Chromatography Data Systems029
13722Audit Trails and Their Review022
13723User Account Management and Application Configuration018
13724IT Support for Data Integrity018
13725GMP meets the Cloud023
13726Workshop: Assessing a System for Data Integrity08
13910Case study: Can Spreadsheets meet Data Integrity Requirements?021
13911Supply Chain Data Integrity024
13912Key Learning Points013

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