Contact Details
Phone: 00 353 (0)90 6471223       Email: info@firstpolymer.com

Computerised Software Validation

Course Dates

To be verified
Booking/Enquiry

Cost: €395(10% discount for Plastic Ireland/Ibec Members) Inclusive of course manual, lunch and refreshments

Dates: To be advised.

CSV Course Topics /Agenda:

  • Introduction to principles of validation, IQ, OQ, PQ, etc.
  • Review of regulatory requirements
  • Review of GAMP Guidelines
  • Risk Analysis
  • Categorisation of the computerised system & validation requirements
  • Guidelines for determining validation effort with risk assessment
  • Approach to new equipment and introduction of new equipment – “Life Cycle Approach”.
  • Responsibilities within the validation project team.
  • FMEA – a tool in validation approach.
  • Validation Documentation: SOP, URS, SDS, FDS.
  • Computerised Systems Life-cycle Project Phases.
  • Categorisation of the computerised system & validation requirements
  • Guidelines for determining validation effort with Risk Assessment Case Studies / Examples will be included in order to best communicate the methodology.

Who Should Attend:
This course is most suitable for those who wish to gain a good understanding of the principle and processes involved in computerised software validation and regulatory requirements.

Venue:
7  Centre  Court, Blyry Business and Commercial Park, Athlone.

DURATION:
1 day course.

The successful completion of this programme by the learner does not lead to an award, but a certificate of attendance is issued to each participant.

Safety Shoes – Not Required on this course

 

 

 

 

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