System validation/qualification

Duration

2-day training

Why this topic?

Production systems for the pharmaceutical and food industries have to comply with ever-stricter legislation. Every company that makes products for the European or American market is subject to the laws of the EMA (European Medicine Agency), FDA (Food & Drug Administration) and/or FAMHP (Federal Agency for Medicines and Health Products). These include GMP (Good Manufacturing Practices, also known as Predicate Rules) including EU GMP Annex 1, 21CFR Part 11 and/or Annex 11.

System validation involves the systematic testing qualification of equipment. There are several approaches are possible, with the one based on the V-cycle being the most used and common approach. A structured and project based approach for the validation of systems. A thorough analysis of the systems, its components set the basis of the tests. Based on this analysis and the functionality of the system, tests are developed and executed to document the functionality and results of the tests.

What can you expect during the training?

  • A good basis of understanding of quality related requirements
  • A structured approach to analyse and understand functionality
  • A good basis of understanding of developing tests
  • All this according to the ISPE vol5 baseline approach of commissioning and qualification
  • Exploring of other (complementary) approaches

For whom?

This training is intended for anyone involved in the development/implementation of production systems for the pharmaceutical sector, the cosmetics industry, the food industry or related sectors where quality is an important factor.

Programme

  • Introduction
  • ISPE
  • Workflow of systems: V model
  • Phasing
  • Design and Validation
  • Risk-Based Approach and ASTM E2500
  • Commissioning & Qualification
  • Tasks and responsibilities
  • Maintenance of validated systems
  • Risk Management
  • What requirements are placed on staff?
  • How to deal with suppliers and subcontractors?
  • What tasks are expected in the various project phases?

Find out more about this training via Amelior or QbDAcademy@qbd.eu.

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