as of 2019 - 12 - 10
2 Personnel
2.A Human Resource Management
Summary
2.A.1 Principles of human resource management
2.A.2 Duties of senior management
2.A.3 Organisational structures
2.A.3.1 Single-line systems
2.A.3.2 Multiple-line systems
2.A.4 Qualification requirements and requirement profiles
2.A.5 Workplace and job descriptions
2.B Training
Summary
2.B.1 Purpose of training
2.B.2 Legal basis
2.B.3 Responsibility for training
2.B.4 Persons who have to be trained
2.B.5 Setting learning objectives
2.B.6 Organisation of training
2.B.7 Trainer qualification
2.B.8 Training methods
2.B.9 Electronic training systems
2.B.9.1 E-learning/Computer-based training
2.B.9.2 Web-based training
2.B.9.3 Blended Learning
2.B.9.4 Learning management systems
2.B.10 Success and effectiveness monitoring
2.B.11 Training system review
2.B.12 Documentation of training
2.C Training Management
Summary:
2.C.1 General Requirements for Training Management
2.C.2 Usage of Electronic Training Management Systems
2.C.2.1 Definition of Terms
2.C.2.2 Advantages
2.C.2.3 Organisational Aspects
2.C.2.4 User Requirement Specification
2.C.2.5 Integration of Electronic Training Management Systems in EDMS/EQMS Systems
2.C.3 Planning, Implementation and Administration of Trainings using Electronic Systems
2.C.3.1 Training Profiles
2.C.3.2 Organisation of Matrices
2.C.3.3 Planning of Training Based on Training Profiles
2.C.3.4 Process Sequence
2.C.3.5 Live Trainings and the Usage of Paper
2.D Health Monitoring and Occupational Health and Safety
Summary
2.D.1 Occupational health examinations
2.D.2 Preventive occupational medical examinations
2.D.3 Safety in the workplace / Occupational health and safety
2.E Function owners subject to public law
Summary
2.E.1 Qualified Person (QP)
2.E.1.1 Requirements of the Qualified Person in accordance with European law
2.E.1.2 Area of responsibility of the Qualified Person in accordance with European Law
2.E.1.3 Organisational appointment/substitution regulations
2.E.2 Head of Production
2.E.2.1 Individual requirements for Head of Production
2.E.2.2 Areas of Responsibility of the Head of Production
2.E.3 Head of Quality Control
2.E.3.1 Individual Requirements for the Head of Quality Control
2.E.3.2 Areas of Responsibility of the Head of Quality Control
2.E.4 Qualified Person in Accordance with Article 103 of Guideline 2001/83/EC
2.E.4.1 Individual Requirements for the Qualified Person in Accordance with Article 103
2.E.4.2 Areas of Responsibility of the Qualified Person in Accordance with Article 103 of Directive 2001/83/EC
2.E.5 Scientific Service in Charge of Information
2.E.5.1 Individual Requirements for the Scientific Service in Charge of Information
2.E.5.2 Areas of Responsibility of the Scientific Service in Charge of Information
2.E.6 Medical sales representatives
2.E.6.1 Individual requirements for medical sales representatives
2.E.6.2 Areas of responsibility of the medical sales representative
2.F References
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