This course provides you with theoretical and practical knowledge from key business fields. You will apply and deepen your understanding of the technical terminology and professional communication skills required in a professional context in a practical way. You’ll learn the requirements for a GMP system, understand which regulations apply, and discover how artificial intelligence is used in the workplace.
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Certificates: Goethe-Test PRO" certificate
GMP - Good Manufacturing Practice" certificate -
Examination: Praxisbezogene Projektarbeiten mit Abschlusspräsentationen
Goethe-Test PRO -
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
Job-related German language support for the commercial and technical sector
Professional Communication in the Workplace (approx. 1 day)
Communication in Typical Professional Situations
Using job-related technical terms in a work context
Understanding job-related texts, work instructions, and company information
Understanding Conversations and Meetings in a Professional Context
Business Correspondence (approx. 2 days)
Layout and Design of Business Letters
Modern salutations and opening lines
Writing Customer-Focused Letters and Emails
AI-powered writing assistance for emails and letters
Reporting in the Workplace
Creating Cover Letters in Accordance with DIN 5008
Artificial Intelligence (AI) in Professional Communication (approx. 1 day)
Overview of AI Tools in the Professional Workplace
Using AI to Support Professional Correspondence
Creating and Optimizing Professional Texts with AI
Opportunities and Limitations of AI in Everyday Work
Professional field of communication management (approx. 3 days)
Communication in the company
Forms of communication in teams
Meetings and presentations
Conflict management
Conducting appraisal interviews
Conducting job interviews
Sales and consultation meetings
Writing offers
Trade fairs and product presentations
Processing complaints
Business Field (approx. 6 days)
Fundamentals of Human Resources, Management, and Labor Law
Fundamentals of Finance and Controlling
Structure and Content of Payroll Processing
Understanding and Interpreting Operational Analyses, Charts, and Statistics
Professional field of marketing (approx. 6 days)
Basics of advertising
Market analysis and market research
Online marketing and e-commerce
Marketing communication
Use of AI in the creation of marketing texts
Business Processes (approx. 7 days)
Restructuring and Process Management
Process Changes Within the Company
Digital Transformation
Energy Management and
Environmental Protection in the Company
Project Management
Occupational field logistics and trade (approx. 8 days)
Production and
Purchasing and procurement
Delivery and transportation
Retail trade
Project work, certification preparation and certification exam "Goethe-Test PRO" (approx. 6 days)
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
Changes are possible, the course content is updated regularly.
The course provides you with the necessary know-how for employment as a commercial and technical specialist, including job-related German language training, in order to achieve successful integration into the German labor market.
Furthermore, you are 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.
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.
The course is also aimed at international professionals with a business or technical background who wish to improve their technical and job-related communication skills in order to enter the German job market.
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.
In addition, the course provides you with job-specific German language training so you can draft business correspondence in accordance with current guidelines and communicate confidently with both internal and external stakeholders. With the “ alfatraining ” certificate, you can demonstrate the professional skills you’ve acquired, making it easier for you to enter the workforce and advance in your career.
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).