Life Science focuses on biotechnological processes for the production of new drugs, food and animal feed, cosmetics, and medical devices. The course therefore begins by teaching regulatory knowledge and practical skills for conducting clinical trials based on the ICH-GCP quality standard. The course then guides participants through the applicable guidelines for quality assurance in production processes and environments in the pharmaceutical industry, as well as in the food and feed industries and in the manufacture of cosmetics. Finally, the course covers the establishment and management of a risk management system based on the Medical Device Regulation (MDR), as well as the DIN EN ISO 13485 standard relevant to the approval of medical devices.
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Certificates: Life Science Manager" certificate
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Additional Certificates: GCP - Good Clinical Practice" certificate
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: 12 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
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. 0.5 days)
Fundamentals of QM
Quality Methods and Quality Tools
Artificial intelligence (AI) in the work process (approx. 0.5 days)
Document review with AI support
Regulatory requirements (AI Act)
Regulatory Framework and Approval of Medical Devices (approx. 1.5 days)
MDR and IVDR
Classification and Conformity Assessment Procedures
Economic operators, notified bodies, and regulatory responsibilities
UDI and Product Registration in EUDAMED
Special Considerations for Software as a Medical Device (Classification, Key Principles of IEC 62304)
Structure and Components of the Technical Documentation
QM – Medical Devices ISO 13485 (approx. 1.5 days)
Structure, Scope, and Application of ISO 13485
Relationship Between MDR/IVDR and ISO 13485
Design and Development Control, Verification, and Validation
ISO 13485 and the FDA Quality Management System Regulation (QMSR/21 CFR Part 820)
Risk Management (approx. 2 days)
Significance of the ISO 14971 Risk Management Standard
Risk Analysis, Risk Assessment, and Risk Control
Risk Management Throughout the Product Life Cycle
Requirements for Management Systems (approx. 2.5 days)
ISO 9001 vs. ISO 13485
Responsibilities, Resources, and Competence Management
Measurement and Test Equipment Management for Medical Devices and Diagnostics
Test Planning and Fundamentals of Statistical Sampling Methods (AQL)
Process-Oriented Quality Management (approx. 2 days)
Importance of processes, process orientation, process description, and process validation
Corrective and Preventive Actions (CAPA Process)
Continuous Improvement Process (CIP)
Fundamentals of Change Control for Approved Products
Documentation Systems (approx. 3 days)
Fundamentals of general QM documentation, document control, and archiving
Validation Parameters (IQ, OQ, PQ)
Technical Documentation According to MDR/IVDR
Fundamentals of Supplier Management (Supplier Qualification, Supplier Audits)
Fundamentals of clinical evaluation and the Clinical Evaluation Report (CER)
Interface Between Clinical Evaluation and Risk Management
Usability Engineering for Medical Devices
Monitoring of Products on the Market (approx. 2 days)
Defect and Complaint Management
Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF)
Vigilance, reporting procedures, and complaint handling
EUDAMED in the post-market context
Communication with regulatory authorities and notified bodies: Feedback and reporting
Audits and Inspections (approx. 1.5 days)
Application of EN ISO 13485
Audit planning, audit execution, and follow-up
Certification bodies or the competent authorities
EN ISO 13485 vs. MDR (Medical Device Regulation)
ISO 13485 as the basis for the global MDSAP (Medical Device Single Audit Program)
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 completing the course, you will have the necessary expertise in clinical trials from a legal, ethical, and administrative perspective—from planning through statistical analysis. Furthermore, you will be familiar with the requirements for a GMP system, as well as the applicable regulations and technical terms, and will be able to apply them confidently. You will also be familiar with the standards and certifications for medical devices and will be able to contribute to the implementation of EN ISO 13485 and ISO 14971.
Science learners, mathematics learners, IT learners, medical learners and people from medical-technical professions and medical documentation, quality officers and all employees in pharmaceutical production, technology, quality control and quality assurance
Life science managers form an interface between technology and health. In this position, you will therefore be in demand in all areas of the job market that involve such an interface function, for example in manufacturing companies in the pharmaceutical, medical technology or food industry, in the healthcare sector, e.g. clinics and laboratories, in biotech companies and research institutes, in companies in the chemical and cosmetics industry as well as in ministries, associations and public administrations in the healthcare and biotech sectors. Your meaningful certificate provides a detailed insight into the qualifications you have acquired.
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).