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Certificates: GMP - Good Manufacturing 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
GMP - Good Manufacturing Practice
Introduction to GMP (approx. 2 days)
EU GMP guidelines, AMG, AMWHV
Authorities, drug approvals, marketing authorization
Key persons
FDA, CFR 21
International regulations
AI in the pharmaceutical environment
SOP system (approx. 2.5 days)
Requirements for SOPs
Structure of SOPs
Document control and version management
Training system (approx. 1.5 days)
Employee qualification
Training planning and documentation
Effectiveness control
Deviation and CAPA management (approx. 2 days)
Deviations and CAPA
Requirements for deviation and CAPA management
Documentation of deviations
Error cause analysis
Corrective and preventive measures
CAPA process
AI-supported data analysis for root cause identification
Change management (change control) (approx. 1 day)
Requirements for change management
Notifiable changes, classification of changes
Risk management in the change process
Change management process
Validation and qualification (approx. 1.5 days)
Device, system and room qualification
Process, cleaning and method validation
Qualification and validation process
Qualification and validation documentation
Quality control (approx. 1 day)
Sampling and testing
stability
Dealing with OOS
Storage status
AI-supported evaluation of test data
Complaints management (approx. 0.5 days)
Complaints
Product recall
Audit management (approx. 0.5 days)
Audit types and audit process
Internal audit and FDA inspection
AI-supported data analysis for audit preparation
Supplier qualification (approx. 0.5 days)
Supplier qualification and evaluation
Review and trending (approx. 0.5 days)
Batch Record Review
Product Quality Review
Management Review
Industrial hygiene in the pharmaceutical industry (approx. 2 days)
Personnel hygiene
Hygiene requirements
Clothing and behavior
Production hygiene
Contamination prevention
Hygiene plans
Documentation (approx. 0.5 days)
GMP documentation and data integrity
AI-supported support for document review
Production rooms - clean rooms (approx. 1 day)
General requirements for production rooms
Requirements for premises including storage areas
Avoidance of cross-contamination
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.
After this course, you will be familiar with the requirements of a GMP system, the applicable regulations and the central processes of pharmaceutical quality management. You will understand the basics of SOP systems, CAPA, change management, audit processes, documentation, quality control, industrial hygiene and cleanroom requirements and be able to classify relevant technical terms with confidence.
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 science students, engineering graduates, production managers, quality officers and all employees in pharmaceutical production, technology, quality control and quality assurance. It is also aimed at all persons who are responsible for compliance with "Good Manufacturing Practice" and want to find out about the core GMP topics.
GMP knowledge is indispensable in almost all areas of the production of pharmaceuticals and active ingredients, as well as cosmetics, food and animal feed. Your newly acquired knowledge will open up numerous new opportunities for you in these sectors.
Your meaningful certificate provides a detailed insight into the qualifications you have acquired and improves your career prospects.
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).