NEW! Two-day GxP Data Integrity Training

Rescop Academy is providing the training GxP Data Integrity Practitioner level on October 24th & 25th in The Netherlands.

Handling of GxP relevant Data should follow the data lifecycle and GxP Data should be captured, maintained, and destroyed compliant conform regulations. How this should be done is described in diverse Data Integrity Guidelines, amongst which ISPE GAMP® 5 Good Practice Guide: Records & Data Integrity, MHRA ‘GXP’ Data Integrity Guidance and Definitions, and FDA Data Integrity and Compliance with CGMP Guidance for Industry.

To help you follow these guides and comply with regulations, Rescop has developed GxP Data Integrity training.

Course content

Proof of Data Integrity becomes more and more requested during audits and inspections. During this training you will learn a structured approach to document the requested proof.

This approach is based on our experience with the requirements from diverse Data Integrity Guidelines and the GAMP® 5 Good Practice Guide: Records & Data Integrity, and can be applied to any system; even paper-based systems.

Furthermore, the biggest and most common data integrity gaps are discussed.

It is shown how to identify these gaps for your systems, and more important, ideas how to close the gaps are shared. Other topics include: how to use Audit Trails, how to properly setup security for Accounts, and how to maintain Data Integrity.

Program

Day 1

  • Module A – Introduction
  • Module B – Regulations & Data Objects

Day 2

  • Module C – Data Integrity in System Design
  • Module D – Data Integrity in System Operation
  • Module E – Data Integrity in System Retirement

Dates & Location

October 24th & 25th 2019
Utrecht
The Netherlands

Investment

Young Professional Fee (graduated after May 2017): € 995,-
Early Registration Fee (prior to September 25th): € 995,-
Regular Fee (from September 25th) € 1125,-
Prices listed are excl. VAT