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Certificates: Certificate "Quality representative with TÜV Rheinland-certified qualification"
GCP - Good Clinical Practice" certificate
Certificate "Quality management in the medical device industry" -
Examination: Practical project work with final presentations
Quality officers with TÜV Rheinland-certified qualifications -
Teaching Times: Full-timeMonday to Friday from 8:30 a.m. to 3:35 p.m. (in weeks with public holidays from 8:30 a.m. to 5:10 p.m.)
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Language of Instruction: German
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Duration: 12 Weeks
Quality officers with TÜV Rheinland-certified qualifications
Basics of quality management (approx. 1 day)
Terms and definitions
Quality management
Quality management systems
Standards and guidelines
Process basics (approx. 1 day)
What is a process?
Process management according to ISO 9001
Identification of processes
ISO 9001 process model
Corporate environment (approx. 1 day)
Context of the organization
Interested parties
Scope of application
Management (approx. 1.5 days)
Commitment to the QM system
Quality policy
Responsibilities and powers
Planning (approx. 1 day)
Dealing with risks and opportunities
Quality objectives and planning
Planning changes
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Support (approx. 2 days)
Resources
Competence
Awareness
Communication
Knowledge of the organization, knowledge management
Documentation of the quality management system
Operation (approx. 2 days)
Operational planning
Requirements for products and services
Product development
Predictive failure avoidance with FMEA, QFD, Poka Yoke
External provision
Supply Chain Act (LkSG) and EU Sustainability Directive (CSDDD)
Production and service provision
Release of products and services
Control of non-conforming results
Evaluation of performance (approx. 1.5 days)
Monitoring and measurement
Internal audit
Management review
Improvement (approx. 1 day)
Non-conformity and corrective actions
Continuous improvement
Auditing and certification (approx. 1.5 days)
Fundamentals of auditing
Internal audits
Audit procedure
Auditing external providers or external parties
Certification audit
Communication (approx. 2 days)
Building blocks of communication
The iceberg principle of communication
The four-ears model
Communication behavior in audits
Project management (approx. 1 day)
Definition of project
Managing projects successfully
Total Quality Management (approx. 0.5 days)
Quality of an organization
ISO 9004: Guidance for achieving sustainable success
EFQM Model for Excellence
Project work, certification preparation and certification examination "Quality Officer with TÜV Rheinland certified qualification" (approx. 3 days)
GCP - Good Clinical Practice
Introduction and definitions (approx. 2 days)
Medical basics and terminology
Legal, regulatory and ethical framework conditions
Planning and organization of studies
Forms of studies, study methodology
Application to an ethics committee
GCP definitions/important GCP documents (approx. 3 days)
Legal basis and regulations in clinical research
National and international principles of pharmaceutical law/ICH-GCP
Declaration of Helsinki
ICH-GCP E6 (R2) regulations
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Introduction to clinical trials (approx. 4 days)
Resource planning
Distribution of tasks in the team
Investigator contract
Relevant documents: protocol, investigator's brochure, information, CRF, etc.
Responsibilities (sponsor, CRO, monitor, investigator)
Introduction to the processes of clinical data management (approx. 3 days)
Electronic recording, plausibility check and coding of study data
Medical statistics and biometrics (approx. 1 day)
Basic statistical concepts
Data management
Database management
Audits/inspections (approx. 2 days)
Informing study participants; §40 and 41 AMG
Documentation and reporting of adverse events
Adverse events: Definitions, reporting channels, reporting deadlines
Quality management of clinical trials
Completion of the clinical trial (approx. 2 days)
Close Out Visit
Archiving and final study reports
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
QM in the medical device industry
Introduction to general quality management (approx. 1 day)
Basics of QM
Q-methods and Q-tools
QM - Medical devices ISO 13485 (approx. 2 days)
Structure, scope, area of application of ISO 13485
Relationship between MDR/IVDR and ISO 13485
ISO 13485 in the context of the requirements of 21 CFR Part 820
Requirements for management systems (approx. 3 days)
Management standard ISO 9001:2015
Provision and management of resources
Basics in the area of measurements and tests
Requirements for measuring equipment management for medical devices/diagnostics
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Process-oriented QM (approx. 4 days)
Meaning of process, process orientation, process description and process validation
Corrective and Preventive Actions (CAPA process)
Continuous improvement process (CIP)
Monitoring products on the market: defect and complaint management, postmarket surveillance (PMS and PMCF), reporting procedures and complaint handling
Communication with the authorities and notified bodies: Feedback and reporting
Documentation systems (approx. 3 days)
Basics of general QM documentation, document control and archiving
Validation parameters (IQ, OQ, PQ)
Summary Technical Documentation: STED
Risk management (approx. 2 days)
Importance of the risk management standard ISO 14971
Product and process risks
Risk areas, typical product risks
Audits and inspections (approx. 2 days)
Application of EN ISO 13485
Certifiers or the responsible authorities
EN ISO 13485 vs. MDR (Medical Device Regulation)
ISO 13485 as the basis for the global MDSAP (Medical Device Single Audit Program)
Auditor duties, audit planning and implementation
Audits taking into account the implementation of legal and technical requirements
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
Changes are possible. The course content is updated regularly.
Once you have completed the course, you will be able to plan, introduce and maintain a quality management system and monitor its effectiveness. You will also have professional knowledge in the application of DIN EN ISO 9001 and in the planning of internal quality audits.
You will also master the legal, ethical and administrative aspects of GCP as well as the specialist knowledge of clinical trials from planning to statistical evaluation.
You are also familiar with the regulations, standards and certifications for medical devices and can contribute to the implementation of EN ISO 13485:2021-12.
The course is aimed at managers and employees who are entrusted with quality management, who are to implement a QM system in practice or who would like to develop in the area of quality management, as well as specialists and managers from production and service companies who are actively involved in the QM system and quality improvement.
Science learners, math learners, IT learners, medical learners and people from medical-technical professions.
Specialists in the field of quality management are in demand from both large and medium-sized companies in industry, trade and the service sector.
After the course, you will be able to demonstrate your new skills with a TÜV Rheinland-certified qualification.
Professional knowledge and consistent adherence to prescribed standards are required to ensure high quality in clinical trials. With these newly acquired skills, you will be in high demand in the pharmaceutical industry or at a contract research organization.
In order for a medical device to be sold on the German and European market, medical device regulations must be complied with during production. Specialists who are familiar with the production process and the applicable quality standards are in high demand in the medical device industry. In addition, such knowledge also helps the pharmaceutical industry to better understand the regulatory requirements at the interface between the pharmaceutical and medical technology industries.
Didactic concept
Your lecturers are highly qualified both professionally and didactically and will teach you from the first to the last day (no self-study system).
You will learn in effective small groups. The courses usually consist of 6 to 25 participants. The general lessons are supplemented by numerous practical exercises in all course modules. The practice phase is an important part of the course, as it is during this time that you process what you have just learned and gain confidence and routine in its application. The final section of the course involves a project, a case study or a final exam.
Virtual classroom alfaview®
Lessons take place using modern alfaview® video technology - either from the comfort of your own home or at our premises at Bildungszentrum. The entire course can see each other face-to-face via alfaview®, communicate with each other in lip-sync voice quality and work on joint projects. Of course, you can also see and talk to your connected trainers live at any time and you will be taught by your lecturers in real time for the entire duration of the course. The lessons are not e-learning, but real live face-to-face lessons via video technology.
The courses at alfatraining are funded by Agentur für Arbeit and are certified in accordance with the AZAV approval regulation. When submitting a Bildungsgutscheinor Aktivierungs- und Vermittlungsgutschein, the entire course costs are usually covered by your funding body.
Funding is also possible via Europäischen Sozialfonds (ESF), Deutsche Rentenversicherung (DRV) or regional funding programs. As a regular soldier, you have the option of attending further training courses via Berufsförderungsdienst (BFD). Companies can also have their employees qualified via funding from Agentur für Arbeit (Qualifizierungschancengesetz).