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Certificates: Certificate "Quality representative with TÜV Rheinland-certified qualification"
Certificate "Quality manager with TÜV Rheinland certified qualification"
GMP - Good Manufacturing Practice" certificate -
Examination: Practical project work with final presentations
Quality officers with TÜV Rheinland-certified qualifications
Quality manager with TÜV Rheinland certified qualification -
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
Quality officers with TÜV Rheinland-certified qualifications
Basics of quality management (approx. 1 day)
Terms and definitions
Quality management
Quality management systems
Standards and guidelines
Process basics (approx. 1 day)
What is a process?
Process management according to ISO 9001
Identification of processes
ISO 9001 process model
Corporate environment (approx. 1 day)
Context of the organization
Interested parties
Scope of application
Management (approx. 1.5 days)
Commitment to the QM system
Quality policy
Responsibilities and powers
Planning (approx. 1 day)
Dealing with risks and opportunities
Quality objectives and planning
Planning changes
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Support (approx. 2 days)
Resources
Competence
Awareness
Communication
Knowledge of the organization, knowledge management
Documentation of the quality management system
Operation (approx. 2 days)
Operational planning
Requirements for products and services
Product development
Predictive failure avoidance with FMEA, QFD, Poka Yoke
External provision
Supply Chain Act (LkSG) and EU Sustainability Directive (CSDDD)
Production and service provision
Release of products and services
Control of non-conforming results
Evaluation of performance (approx. 1.5 days)
Monitoring and measurement
Internal audit
Management review
Improvement (approx. 1 day)
Non-conformity and corrective actions
Continuous improvement
Auditing and certification (approx. 1.5 days)
Fundamentals of auditing
Internal audits
Audit procedure
Auditing external providers or external parties
Certification audit
Communication (approx. 2 days)
Building blocks of communication
The iceberg principle of communication
The four-ears model
Communication behavior in audits
Project management (approx. 1 day)
Definition of project
Managing projects successfully
Total Quality Management (approx. 0.5 days)
Quality of an organization
ISO 9004: Guidance for achieving sustainable success
EFQM Model for Excellence
Project work, certification preparation and certification examination "Quality Officer with TÜV Rheinland certified qualification" (approx. 3 days)
Quality manager with TÜV Rheinland certified qualification
Basics of process management (approx. 2 days)
Recognize and systematize processes
Visualize and analyze processes
Mastering processes - control variables, key figures
Improving and reorganizing processes
Process management in planning, logistics and service - Production and service
Tools for process management (approx. 3 days)
Application of standard tools, including process flow diagram, cause-effect diagram, histogram, scatter diagram, Pareto diagram
7 management tools and their function - affinity diagram, relation diagram, tree diagram, matrix diagram, portfolio diagram, problem-decision plan, network diagram
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Planning with FMEA and QFD and Design Thinking (approx. 2 days)
The Failure Mode and Effects Analysis: Quality Function Deployment (QFD)
Design Thinking
Statistical methods and evaluation procedures (approx. 2 days)
Types of statistics
Descriptive statistics - Visualization
Inductive statistics - Static
The world of Six Sigma (approx. 1 day)
Meeting customer expectations with Six Sigma
Six Sigma and the spread in the process
The Six Sigma method in practice
It doesn't work without employee participation
The DMAIC cycle: Five steps to success
The history of quality awards (approx. 0.5 days)
The quality prizes at a glance
Japan: The Deming Prize
USA: The Malcolm Baldrige National Quality Award (MBNQA)
The EFQM Levels of Excellence program
The EFQM Model for Excellence (approx. 0.5 days)
Orientation in the EFQM model
Realization in the EFQM model
Results in the EFQM model
EFQM diagnostic tool: RADAR
EFQM Recognition: Ludwig Erhard Prize Basic concepts of excellence
The Balanced Scorecard (BSC) (approx. 1 day)
Perspectives of the BSC
Alignment of the organization with the strategy
BSC pyramid, BSC process
Benefits of the BSC
Learning from the best - Benchmarking (approx. 0.5 days)
Origins of benchmarking
Benchmarking methods
Procedure of a benchmarking process
The continuous improvement process (approx. 1 day)
Kaizen and the continuous improvement process
Dealing with non-conformities (errors, prevention, correction)
Classification of errors
Further building blocks of the CIP
Employee orientation (approx. 0.5 days)
Necessity of employee orientation and
-qualification
Employee orientation and the EFQM model
Employee orientation as a management task
Employee appraisal
Employee survey
Knowledge management
Legal basics (approx. 0.5 days)
The areas of law
National law, European law
Relationship between EU law and national law
LkSG - Supply Chain Due Diligence Act
Product and manufacturer liability (approx. 1 day)
Product liability from contract - material defects,
Warranty claims, positive breach of contract, burden of proof and statute of limitations, delimitation of warranty, commercial obligation to give notice of defects
Statutory product liability claims
Strict liability under the German Product Liability Act (ProdHaftG)
Product liability under administrative law
Criminal product liability
Damage avoidance strategies (approx. 1.5 days)
Drafting contracts (contract management, general terms and conditions, limitations of liability)
Quality assurance agreements
quality management
organization
documentation
Project work, certification preparation and certification examination "Quality Manager with TÜV Rheinland certified qualification" (approx. 3 days)
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.
Once you have completed the course, you will be able to plan, introduce and maintain a quality management system and monitor its effectiveness. You will also have professional knowledge in the application of DIN EN ISO 9001 and in the planning of internal quality audits.
You can also plan and implement quality management systems. You handle measurements, controls and problem solving with confidence and have competent knowledge of strategic management methods.
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.
The course is aimed at managers and employees who are entrusted with quality management or who are to implement a QM system in practice, as well as specialists and managers from production and service companies who are actively involved in the QM system and quality improvement.
Specialists in the field of quality management are in demand from both large and medium-sized companies in industry, trade and the service sector. After the course, you will be able to provide meaningful proof of your new skills with a TÜV Rheinland-certified qualification.
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).