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Mastering Challenges of Data Integrity and System Validation

Wed, 17 Oct 2018, 09:00 AM (CEST)
-
Thu, 18 Oct 2018, 06:00 PM (CEST)
Registration deadline: Mon, 15 Oct 2018, 09:00 AM (CEST)
Berlin Marriott HotelBerlin, GermanyOpen in Google Maps

€ 1,495.00

Data Integrity is currently a hot topic in the pharmaceutical industry and in the focus of health authority inspections.
Mastering Challenges of Data Integrity and Computer System Validation

A properly validated computer system allows to establish and maintain over time the data integrity: once the regulatory requirements are met through a consistent and rigorous validation process, this implies that the required controls are in place.

This 2-day training course provides practical guidance to understand the basics of data integrity and computer system validation and offers real world learning examples of integrated approaches. A mixture of lectures and interactive sessions provides a maximum of learning success.

On the first day the focus is on regulatory foundation of data integrity, ALCOA(+) principle, data governance, modelling of data/process flows, and hybrid systems. The second day consists of workshops around risk evaluation and presentation/discussions about general principles of computer system validation and audit trail reviews.

Who Should Attend
  • Managers responsible for IT systems in pharma and
    supplier companies
  • Validation Managers
  • Laboratory Supervisors
  • Production Supervisors
  • QA Managers
  • Everybody, who is involved in the topics of Data Integrity and
    Computer System Validatio


**********************************************************************
FURTHER INFO

» PDA Homepage
» Training Course Homepage
» Registration

For further questions please contact
+49 (0)30 436 5508-0

**********************************************************************

 


Mastering Challenges of Data Integrity and Computer System Validation

A properly validated computer system allows to establish and maintain over time the data integrity: once the regulatory requirements are met through a consistent and rigorous validation process, this implies that the required controls are in place.

This 2-day training course provides practical guidance to understand the basics of data integrity and computer system validation and offers real world learning examples of integrated approaches. A mixture of lectures and interactive sessions provides a maximum of learning success.

On the first day the focus is on regulatory foundation of data integrity, ALCOA(+) principle, data governance, modelling of data/process flows, and hybrid systems. The second day consists of workshops around risk evaluation and presentation/discussions about general principles of computer system validation and audit trail reviews.

Who Should Attend
  • Managers responsible for IT systems in pharma and
    supplier companies
  • Validation Managers
  • Laboratory Supervisors
  • Production Supervisors
  • QA Managers
  • Everybody, who is involved in the topics of Data Integrity and
    Computer System Validatio


**********************************************************************
FURTHER INFO

» PDA Homepage
» Training Course Homepage
» Registration

For further questions please contact
+49 (0)30 436 5508-0

**********************************************************************

 


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