Systems GxP, data integrity, quality, validation

Data integrity of computerized systems (1 day)

 

Objectives of internship 

  • Knowing how to independently carry out a GxP risk analysis on all types of systems and articulated around regulatory requirements (GMP, Part 11, ICH Q9, Part 820, Data Integrity).
  • Understand what data integrity is and why it has become so important
  • Learn why there are so many data integrity issues
  • Know and understand the key requirements of the various regulatory guidelines Data integrity: FDA / EU / PICS / MHRA / WHO
  • Being able to specify and validate software in accordance with Part11 / Annex 11 requirements
  • Learn how to ensure and document the integrity of GxP data and other records according to Part 11 and EU Annex 11
  • Understand new and future FDA practices on Part 11 inspections and controls.

Teaching methods

  • Course based on ISPE, GAMP 5 and Data Integrity guidelines
  • Presentation and delivery of a complete course material
  • Duration: 1 day

Staff concerned

  • Quality assurance and validation manager for the pharmaceutical, medical devices, pharmaceutical chemistry and cosmetics sectors
  • Prerequisites: have basic knowledge of validation according to GAMP 5

Dates and costs 2022

June 14th 2022 – Paris / October 26th 2022 – Lyon
Cost: € 680 excluding VAT including breaks and lunch.

DETAILED PROGRAM

1 — Definitions, requirements and approaches for Data Integrity

  • Introduction
  • Context – trends warning letters FDA Data integrity
  • Meaning of Data Integrity: ALCOA principles
  • Data Integrity key points of regulatory guidance
  • Examples of Data integrity checks

2 — RISK ANALYSIS

  • ALCOA: what can inspectors check?
  • Implementation of key concepts of Data integrity according to the FDA:
    • Audit Trail
    • System Validation
    • Contribution of risk analysis
    • Governance

3 — APPLICATION OF THE METHOD BY THE INTERNS

  • Case studies chosen from among the trainees
  • Restitution
  • Enrichment and comments from the facilitator

Pre-registration:

4 + 15 =

 

Pharmasys is an approved organization (activity declaration number: 11 91 0806691) and listed in Datadock. It is therefore quite possible to go through your OPCA for the financing of the latter. You will find all the information you need to create your request for assistance in the training contract that will be sent to you.

We are at your disposal for any request for additional information.

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PHARMASYS GROUP
36, Place Nelson Mandela
91300 MASSY
Tel : +33 (0)1 69 35 05 43
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