• CHEM4213
  • Principles of Val for Med Prod

  • Credits (ECTS): 5
  • Food Science and Environmental Health

Modules are delivered
as part of a programme.
To apply for the
programme,
see the DIT website

Learning Outcomes And Assessment

Assessment

Description Weight [%]
Examination 60
Assessment 40
Minimum thresholds may apply.
For further details please refer to your Student Handbook or the Programme Document which is available from the DIT Library.
Learning Outcomes

On Completion of this module, the learner will be able to
1. Be aware of the history and evolution of validation in the pharmaceutical industry, from pre-validation times to the present risk-based validation environment
2. Learn about validation in the following areas - changeover, processing, equipment, analytical, shipping, computer systems
3. Get an introduction to the use of Lean Six Sigma methodology in the modern pharmaceutical validation environment
4. Gain an understanding of the need for validation, from a legal and ethical point of view
5. Be able to design and implement a Validation study
6. Be able to critically evaluate a pharmaceutical companies VMP [validation master plan]

Please note that the catalogue is provided as a guide to modules in DIT. Not all modules listed will necessarily be offered every year and new modules may also be added. Information subject to change. For detail on specific programmes/modules please contact the relevant School directly.