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Certificates: GCP - Good Clinical Practice" certificate
Certificate "Quality management in the medical device industry" -
Examination: Praxisbezogene Projektarbeiten mit Abschlusspräsentationen
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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: 8 Weeks
GCP - Good Clinical Practice
Introduction and definitions (approx. 2 days)
Medical basics and terminology
Legal, regulatory and ethical framework conditions
Overview of the EU Clinical Trials Regulation (EU-CTR)
CTIS - function and classification in the European study approval procedure
Planning and organization of studies
Types of studies, study methodology
Application to an ethics committee
Overview of digital tools and AI applications in clinical research
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 (R3) regulations
Interaction of ICH-GCP, EU-CTR and CTIS in the regulatory environment
Limits and regulatory requirements for the use of AI in clinical trials
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)
Actors involved in the CTIS process
Basic procedure for study approval via CTIS
Digital infrastructure of clinical trials
Support of study planning by AI (e.g. literature search, protocol design)
Introduction to the processes of clinical data management (approx. 3 days)
Electronic recording, plausibility checks and coding of study data
AI-supported data checking, plausibility checks and coding
Data quality and automation in clinical data management
Medical statistics and biometrics (approx. 1 day)
Basic statistical concepts
Data management
Database management
Audits/inspections (approx. 2 days)
Informing study participants; legal basis according to §40-42e AMG
Documentation and reporting of adverse events
Adverse events: Definitions, reporting channels, reporting deadlines
Quality management of clinical trials
Transparency requirements and public study information in the context of CTIS
AI-supported document review and quality control
Completion of the clinical trial (approx. 2 days)
Close Out Visit
Archiving and final study reports
Final notification and study status in the European context (CTIS overview)
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. 1.5 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
Artificial intelligence (AI) in the work process (approx. 0.5 days)
Document review with AI support
Regulatory requirements (AI Act)
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 and diagnostics
Process-oriented QM (approx. 2 days)
Importance of processes, process orientation, process description and process validation
Corrective and Preventive Actions (CAPA process)
Continuous improvement process (CIP)
Monitoring products on the market (approx. 2 days)
Error and complaint management
Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF)
European database EUDAMED
Reporting procedures and complaint handling
Communication with 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 and typical product risks
Audits and inspections (approx. 2 days)
Application of EN ISO 13485
Certifiers and 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.
You master the legal, ethical and administrative aspects of GCP as well as the specialist knowledge of clinical trials from planning to statistical evaluation.
You will also be familiar with the regulations, standards and conformity assessment procedures for medical devices and be able to contribute to the implementation of EN ISO 13485:2021 and ISO 14971:2021.
Science learners, math learners, IT learners, medical learners and people from medical-technical professions.
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).