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Certificates: Certificate "Six Sigma Yellow & Green Belt"
GMP - Good Manufacturing Practice" certificate -
Examination: Practical project work with final presentations
Six Sigma Green Belt exam -
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
Quality management - Six Sigma Yellow & Green Belt
Six Sigma Yellow Belt (approx. 1 week)
Introduction to the Six Sigma strategy
The Six Sigma organization: roles and tasks
The DMAIC method
Define phase
Customer requirements (Voice of Customer)
Specific project requirements (CTQs)
Problem identification and description
Process visualization (SIPOC diagram)
Measure phase
Process Mapping, Cause & Effect Matrix
Process capability and process indicators
Fundamentals of statistics
Introduction to statistical software incl. graphical methods
Analysis phase
Data analysis methods (overview)
Cause-effect analysis (fishbone diagram, Ishikawa)
Risk analysis (FMEA)
Improve phase
SWOT
Generate solution ideas
Estimate financial impact
Control phase
Control plan
Poka Yoke
Documentation
Project work
To deepen the content learned
Presentation of the project results
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Six Sigma Green Belt (approx. 3 weeks)
Project management with Six Sigma
Green Belts as project management
Teamwork and leadership
Define phase
Define project and create project order
Determining costs and formulating objectives (benefits)
Team composition, schedule and milestones
Measure phase
Reliable and representative data collection Measurement System Analysis (MSA)
Graphical representation of data
Analysis phase
Process capability analysis
Statistical test & analysis methods (ANOVA etc.)
Methods of process visualization
Focusing and hypothesis development
Improve phase
SWOT
Design of Experiments (DoE)
Select and implement solutions
Control phase
Development of a process monitoring plan
SPC control charts
Review of the results of the improvement project
Presentation of the results
Integration into existing QM systems
Project work
To deepen the content learned
Presentation of the project results
Six Sigma Green Belt exam
GMP - Good Manufacturing Practice
Introduction to GMP (approx. 2 days)
EU GMP guidelines, AMG, AMWHV
Manufacturing authorization and supervisory authorities
Authorization and regulatory authorities
Personnel in key positions (organization chart)
CFR 21 - The American supervisory authority FDA
International GMP regulations (WHO, PIC, etc.)
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Pharmaceutical quality system (approx. 11 days)
Introduction
Responsibility of the management
Quality management manual
Structure and objectives of the PQS
SOP system
Requirements for SOPs
Structure of an SOP
SOP system
Control of Q-documents using the example of SOPs
Training system
Requirements for employee qualification
Training planning, training documentation
Monitoring the success of training courses
Deviation and CAPA management
What is a deviation?
Documentation of deviations
Corrective and preventive measures
Root cause analysis
Deviation processing/CAPA process
Change management (change control)
Requirements for change management
Notifiable changes, classification of changes
Procedure
Risk management
Validation/qualification
Qualification of devices/systems and rooms
Process validation, cleaning and method validation
Qualification and validation process
Documentation requirements
Quality control
Sampling, quality tests
Stability tests
OOS procedure
Complaints management
Complaints
Product recall
Audit management
Audit types
Audit process
Internal audit
FDA inspection
Supplier qualification
Review/Trending
Batch Record Review
Product Quality Review
Management Review
Industrial hygiene in the pharmaceutical industry (approx. 2 days)
Personnel hygiene
General hygiene requirements
Health monitoring
Clothing regulations
Behavior in clean areas
Production hygiene
The main sources of contamination
Measures to prevent contamination
Hygiene plans
Documentation (approx. 0.5 days)
Basic requirements for documentation
Data Integrity
Production rooms - clean rooms (approx. 1 day)
General requirements
Requirements for the premises
Avoidance of cross-contamination
Storage (approx. 0.5 days)
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 enables you to implement Six Sigma projects independently and successfully in accordance with ISO 13053-1:2011-09. You will be able to use the specific tools and methods with confidence and thus implement complex improvement projects responsibly.
Furthermore, you are familiar with the requirements of a GMP system, know which regulations must be applied and can use these for your own problems as well as understand and explain specific technical terms. You will also be familiar with the basics of the CAPA system.
People with a degree in engineering, technicians, foremen and specialists from the production and service sectors and people from the areas of quality management, administration and sales who want to carry out and manage improvement projects using the Six Sigma method.
Six Sigma is an internationally standardized and recognized method of quality management and a management tool for process improvement. By obtaining the Green Belt, you demonstrate your mastery of the methodology in your profession. As a Six Sigma project manager, you will be in demand across all industries in medium-sized and large companies, thus enhancing your career profile in the long term.
Additional GMP knowledge is essential 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).