Data integrity and applied risk analysis of computerized systems (2 days)

Objectives of the internship

• Acquire a concrete, robust, structured and repeatable method of GxP risk analysis of computerized systems in accordance with Data Integrity requirements
• 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).
• Meet GxP requirements in this area, in accordance with recent FDA guidelines and the latest Data Integrity GxP guidelines.
• Know how to prepare the validation of its computerized systems using the “Risk Analysis” approach

Teaching methods

• Course based on ISPE and GAMP5 guidelines and Data Integrity guidelines
• Concrete case studies on different types of systems: Excel, automation, clinical trials, Supervision, Lab, Batch, ERP
• Work in sub-groups followed by the facilitator
• Presentation and submission of a summary document
• Duration: 2 days

Staff concerned

• Responsible for technical services, quality assurance and validation of the pharmaceutical, medical devices, pharmaceutical and cosmetic chemicals sectors
• Prerequisites: have basic knowledge of validation according to GAMP 5

Dates and costs 2022

June 15th-16th 2022 – Paris / October 26th-27th 2022 – Lyon
Cost: 1080 € excluding VAT including breaks and lunch.

DETAILED PROGRAM

1 — REMINDER OF THE VALIDATION CONCEPTS OF COMPUTER SYSTEMS

• System regulations in force
• Definitions, life cycle and validation activities
• Key points of Data integrity requirements (FDA and Europe)
• Key points of the “Risk Analysis” approach

2 — RISK ANALYSIS

• Standards, methods and standard tools: ISO14971, ICH Q9, FMEA / FMECA …
• Limits and constraints of standard tools
• Detail of the GAMP® methodology for computerized systems risk analysis: phases, steps and records
• Presentation of the simple, structured and robust method of GxP risk analysis of computerized systems:
  • Global criticality analysis GxP & GAMP software categories: definition of the modular validation effort
  • Functional risk analysis: definition of risk control measures to guarantee Data integrity
  • Change control: risk approach making it possible to define a modular effort for exchange management
• Examples of applications for different systems: Excel, PLC, clinical trials, Supervision, LIMS, Batch, ERP

3 — APPLICATION OF THE METHOD BY INTERNS

• From the educational example presented, the trainees carry out in sub-groups a GxP risk analysis covering the different types of systems: automation, ERP / MES, LIMS, Excel application …
• Restitution
• Enrichment and comments from the facilitator

4 — KNOW HOW TO ANIMATE A COMPUTER SYSTEM RISK ANALYSIS

• The main rules of animation
• Scenarios for interns

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.