2 days
1150
€ H.T including breaks and lunch
Objectives of the internship
- Acquire a concrete, robust, structured and repeatable GxP risk analysis of computerized systems in accordance with Data Integrity requirements and the new CSA FDA guidance (draft).
- Know how to independently carry out a GxP risk analysis on all types of systems and based on regulatory requirements (GMP, Part 11, ICH Q9, Part 820, 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 for the validation of your computerized systems using the “Risk Analysis” approach
Teaching methods
- Course based on the ISPE guidelines, GAMP5 (2nd edition) 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 delivery of a summary document
Staff concerned
- Responsible for technical services, quality assurance and validation of the pharmaceutical, medical devices, pharmaceutical and cosmetic sectors
- Prerequisites: have basic knowledge of validation according to GAMP 5 (2nd edition).
Detailed program
1 — REMINDER OF THE CONCEPTS OF VALIDATION OF COMPUTER SYSTEMS
- Existing system regulations
- 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
- Norms, methods and standard tools: ISO14971, ICH Q9, FMEA/FMECA...
- Limits and constraints of standard tools
- Detail of the GAMP methodology®risk analysis of computerized systems: phases, stages and records
- Presentation of the simple, structured and robust GxP risk analysis method for computerized systems:
- Global criticality analysis GxP & GAMP software categories: definition of the modular validation effort
- Functional risk analysis: definition of risk control measures to ensure data integrity
- Change control: a risk approach to define a modular effort for exchange rate management
- Examples of applications for different systems: Excel, automaton, clinical trials, Supervision, LIMS, Batch, ERP
3 — APPLICATION OF THE METHOD BY THE TRAINEES
- Based on the educational example presented, the trainees conduct a GxP risk analysis in sub-groups covering the various types of systems: automation, ERP/MES, LIMS, LIMS, Excel application...
- Restution
- Enrichment and comments from the presenter
4 — KNOW HOW TO CONDUCT A COMPUTERIZED SYSTEM RISK ANALYSIS
- The main rules of animation
- Placement of trainees in situations
