Equipment Validation
COST:
€ 795 per person, inclusive of course manual, lunch and refreshments.
2 day course.
This course is designed to provide detailed understanding of equipment validation for regulated industries, with particular focus on validation..
If you purchase or develop a new piece of equipment that is used to manufacture medical devices, in-vitro medical devices or pharmaceutical products EU and FDA regulations require that firms have a quality system programme in place for the following
• Calibration and maintenance of equipment
• When equipment is installed that it is done correctly against best industry practice to ensure it operates as intended against URS ( User Requirement Specification), FDS ( Functional Design Specification) and to ensure proper SAT (Site Acceptance Testing) and FAT (Factory Acceptance Testing) is completed.
• This equipment must pass through the above toll gates to be considered ready for PQ ( Performance Qualification) testing and generation of a design space for that process. This design space must consider the key inputs to the process which can be developed by carrying out design of experiments using Orthogonal arrays.
• You then must guarantee reproducibility of the process by carrying out validation studies with this equipment
The course aims to explore these in some depth validation activities, the regulatory reasons of these activities and how best to meet these requirements.
Course Topics:
• Short review of principles of validation.
• Review of regulatory requirements: ISO EN 13485, QSR, Guidance Documents
• Responsibilities within the validation project team
• URS,FDS,SAT and FAT
• Worst Case Scenario
• Validation Documentation Stages and documents: SOP, MVP, IQ, OQ, PQ and Validation
• Change Control and Validation
• Retrospective/Prospective Validation
• Design of Experiments and its useful approach to validation projects
• Failure Mode Effect Analysis as a tool in Validation
All of these topics will be expanded on and Case Studies / Examples will be included in order to best communicate the method for validation
Venue:
First Polymer Training,
7 Centre Court,
Blyry Business & Commerical Park,
Athlone,
Co. Westmeath
Convenient Hotels: (w/parking)
Creggan Court Hotel Athlone Tel: 090-6477777
Radisson SAS Northgate Street, Athlone . Book through us for a special rate.
Engineers Ireland CPD Scheme
In 2009, FPTS became a registered training provider with Engineers Ireland, recognising FPTS as a training provider who offers relevant learning opportunities for the career development of Engineers Ireland (EI) members.
Each FPTS course attended allows EI members to gain credits under the CPD scheme.
