Deutsch Francais

Training

  • Elaboration of training modules for both:
    • Classroom training (including paper documentation)
    • Computer based training (e-learning)
  • Organization and moderation of workshops by customers

Quality Risk Management (according to ICH Q9)

Training for:

  • Business & process owner, system owner
  • Project manager
  • Project team member
  • System / software developer
  • Management members
  • Member of quality units (e.g. Quality Assurance)

Modules:

  • Introduction to ICH Q9
  • ICH Q9, ASTM E2500-07, GAMP® 5
  • High Level Risk Assessment (HLRA)
  • System Risk Assessment (SRA)
  • Functional Risk Assessment (FRA)
  • Risk management and optimization of the test effort
  • Tools & methodology: FMEA, HAZOPS, ...
  • Risk based approach for projects

Good Engineering Practices

Training for:

  • Business & process owner, system owner, users
  • Project manager
  • System / software developer
  • Management members
  • Member of quality units (e.g. Quality Assurance)

Modules:

  • Lifecycle
  • Elaborating good requirements and specifications
  • Requirement management, requirement identification
  • Configuration management
  • Change management
  • Design review
  • Test management
  • Data management / record management
  • System management

e-Compliance / Electronic compliance

Within the regulated industry - in particular in the healthcare sector -, e-Compliance covers generally at least Computerized System Validation (CSV) and all topics related to the correct use and management of electronic records and electronic signatures (ERES).

Training for:

  • System owner, users
  • Project manager
  • System / software developer
  • Management members
  • Members of quality units (e.g. Quality Assurance)

Modules:

  • cGxP compliant lifecycles
  • Requirement management, traceability matrix
  • Data integrity
  • Test management
  • Configuration management
  • Compliance and project management
  • Data management / record management
  • Electronic data archiving
  • System management
  • Introduction to EU's Annex 11 and 21CFR Part 11
  • Annex 11 and 21CFR Part 11: rules and examples
  • CSV-case study : the inspector/auditor point of view
  • History of the validation

Information


To contact the webmaster

Last update: 2017-01-01

© Copyright 2002-2017; all rights reserved by Kereon AG