Data Integrity: regulatory compliance and controlling corporate data assets

Home > Data Integrity: regulatory compliance and controlling corporate data assets

Objectives

  • Understanding Data Integrity requirements
  • Knowing how to organise compliance
  • Knowing how to remain proactive with regard to Data Integrity

Audience concerned

– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Heads of Departments such as: Production, R&D, Purchasing, etc.

Aim

Acquiring fundamentals/further development

Programme summary

  1. Introduction and aims of IT system validation
  2. The pharma, MD, cosmetics, multivigilance context of regulated data integrity
  3. Definition and terminology, ALCOA and the life cycle of data
  4. Requirements for IT systems, registrations, discrepancies, and remediation
  5. Variances, the most common risks corporate regulatory authorities look for
  6. Data management
  7. Conclusion

Prerequisites

Have an awareness of IT Systems.

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CADATA

Informations and registration : academy@caduceum.co.uk