SAFE08038 2019 Regulatory Affairs

Examine the role of Regulatory Affairs in relevant industries from a product design, approval, process, liability and risk management perspective.

Recognise and apply the concepts of Good Manufacturing Practice (cGMP), Corrective and preventive action (CAPA) as applied to a regulated environment.

Examine product safety and regulatory requirements and develop a product liability prevention programme.

Analyse the requirements of the EU machinery directive, apply them to a machinery manufacturer and carry out relevant risk assessments.

Interpret and appraise Food Safety Standards in a manufacturing environment. 

This module will be delivered fulltime. This will include lectures, group sessions, and site visits augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a means of assessment (e.g. quizzes, uploading assignments and journals).

Module will be assessed by Continuous assessment (100%) Students will be assessed summatively through continuous assessment of group and individual work. Students will have opportunities to formatively assess their own knowledge through participation in class discussions and questions and answers sessions. Formative feedback will be given in class on an ongoing basis.

Repeat assignments will be available, subject to IT Sligo Procedure on late
submissions, 'Applications for extension of continuous assessment deadlines'.

History and development of standards in relation to regulated environments

ISO 13485 QMS Medical Devices, FDA,  ISO 14971 Risk Management for Medical Devices; Product Liability Prevention Programmes.

Machinery Directive; Standards related to Machinery design, operation, control systems; self-certification for CE Marking

Elements of  management systems in relation to regulated environments; policy, planning, implementation, operation, performance measurement, product liability, consumer protection checking and corrective action, management review

Defining roles and assigning responsibilities in relation to Regulatory Affairs

The concept and management of Corrective and Preventive Actions (CAPA) in a regulated environment

Examine the interaction of Regulatory Affairs and Occupational Health & Safety management. 

BRC Global Standard on Food Safety;  the standardisation of quality, safety and operational criteria and assurance that manufacturers fulfil their legal obligations and provide protection for the end consumer.