The aim of this module is to systematically explore the role of Regulatory Affairs in business management, covering Safe Product Design, Medical Device Directive, FDA regulations, GMP & CAPA, Machinery Directive & Food Safety Management Systems.

1. Examinethe role of Regulatory Affairs in relevant industriesfrom a product design, approval, process, liability and risk management perspective.

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

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

4. Analysethe requirements of the EU machinery directive, apply them to a machinery manufacturer andcarry outrelevant risk assessments.

5. Interpret and appraise Food Safety Standards in a manufacturing environment.

This module examines the role of ergonomics in occupational loss control from the human factors perspective including the individual, the task and the organisation.

1. Analyse organisational failures inherent in accident causation.
2. Assess root cause factors and make recommendations for corrective actions.
3. Appraise the role of human factors in OSH loss.

4. Describe and justify ergonomic principles for safer, healthier and more efficient and effective activities in the workplace.

5. Evaluate and propose ergonomic interventions to manage OSH risks.

The aims of this module are to consider and evaluate behavioural based safety approaches in the workplace and to consider best practice in the development, delivery of these programs. Having completed this module students should be able to: understand key concepts and theories relating to behavioural and belief based safety approaches; recognise behavioural based approaches and their application to the workplace; examine best practice; and evaluate behavioural based safety programs.

1. Demonstrate knowledge of key concepts and theories relating to behavioural and belief based safety approaches

2. Recognise behavioural based approaches and their application to the workplace

3. Review evidence based literature on behavioural based safety

4. Examine best practice in behavioural based safety.

5. Evaluate behavioural based safety programs

This module will look at the need for effective project management in occupational safety and health. The role of the leader along with the development of personal and professional skills will be explored to assist the practitioner of occupational safety and health in a professional environment.

1. Appraise current and historical management theories and their relevance to the modern workplace

2. Analyse the stages in effective project management with particular reference to occupational safety and health activities

3. Explore the roles adopted by team members in a functional project management group and reflect on ones own skills and attributes in the context of project management

4. Identify the barriers to effective project management and develop strategies to minimise their influence

5. Consider the wide variety ofresources available to the safety practitioner in the managementof a project

The aim of this module is to provide students with the knowledge, skill and competence to effectively identify manual handling training requirements and deliver manual handling training. This module is the equivalent of the QQI Special Purpose Award Instructing Manual Handling 6N0233.

1. Have a basic knowledge of the legislation in relation to manual handling in the workplace.

2. Recognise and describe risk factors associated with manual handling activity and workplace conditions and the development of musculoskeletal disorders, particularly to the back.

3. Describe and demonstrate safe handling practice and workplace organisation to reduce risk of the development of musculoskeletal disorders.

4. Design and communicate instruction for safe handling practice and its importance in the workplace.

5. Performmanual handling risk assessments.

6. Constructively critique and adapt manual handling training and development plans.

The aim of this module is to provide students with the knowledge and skills to conduct ergonomic hazard identification and risk assessment of workplace workstations and examine suitable organisational and operational controls.

1. Have a basic knowledge of current health & safety legislation in relation to workplace workstations.

2. Identify ergonomic risk factors, hazards and risks of workplace workstations and explain their association with musculoskeletal disorders.

3. Complete an ergonomic workstation risk assessment.

4. Identify practical solutions to reduce workers risk of developing musculoskeletal disorders.

5. Communicate the findings from ergonomic risk assessment and offer recommendations of basic principles for securing safety and health in the workplace.

6. Constructively critiqueergonomic risk assessment methods.

The purpose of this module is to enable the learner to acquire the knowledge, skill and competence to deliver and evaluate a training intervention within a range of training and development contexts. This module is the equivalent of the QQI Special Purpose Awards in Training Delivery and Evaluation 6N3326 (Train the Trainer).

1. Demonstrate a broad range of knowledge on trainingand development practice and oftherole of training and development across a range of organisations.

2. Demonstrate and applykey principles and theoreticalconceptsintraining delivery,evaluation and effectiveness.

3. Appraise a range of evaluation models and techniques used in evaluation and development intervention.

4. Develop and deliver appropriate training content and materials.

5. Reflect on personal and professional practice, evaluating the impact on others within a training and development context.

The purpose of this module is to equip the learner with the knowledge, skill and competence to identify training and development needs at organisational and individual levels and to scope and devise a training plan and materials which will meet those needs. This module is the equivalent of the QQI Special Purpose Awards in Training Needs Identification and Design 6N3325.

1. Demonstrate a broad range of knowledge on trainingand development practice and oftherole of training and development across a range of organisations.

2. Demonstrate and applykey principles and theoreticallyconcepts underpinning training and development within a range of contexts.

3. Select from appropriate tools and techniques to identify training and development needs.

4. Conduct a training needs analysis to identify training and development needs and devise a training plan

5. Design a training intervention and develop appropriate training content and materials and reflect on practice.