Equipment 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.