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Certificates: Certificate "GMP Project and Process Manager"
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Additional Certificates: Basic certificate in project management (GPM)® from PM-Zert
Certificate "Process manager with TÜV Rheinland certified qualification"
GMP - Good Manufacturing Practice" certificate
Certificate "Six Sigma Yellow & Green Belt" -
Examination: Practical project work with final presentations
Certification by PM-ZERT, certification body of the GPM Deutsche Gesellschaft für Projektmanagement e. V.
Process manager with TÜV Rheinland-certified qualification
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: 16 Weeks
Project management incl. certification by PM-ZERT, certification body of GPM Deutsche Gesellschaft für Projektmanagement e. V. V.
Context skills (approx. 2 days)
Strategy
Governance, structures and processes
Power and interests
Technical skills (approx. 7 days)
Project design
Requirements and objectives
Scope of services and delivery objects
Process and deadlines
Organization, information and documentation
Stakeholders
Opportunities and risks
Agile project management
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Presentation options for project management with MS Project (approx. 5 days)
Introduction to MS Project
Cost plan and financing
Resource planning
Planning and control
Reporting
Personal and social skills (People) (approx. 1 day)
Personal communication
Project work, certification preparation and certification examination in project management (approx. 5 days)
By PM-ZERT, certification body of the GPM Deutsche Gesellschaft für Projektmanagement e. V.
Process manager with TÜV Rheinland-certified qualification
Basics of process management (approx. 2 days)
Understanding and terms in process management
Components of processes
Process map and process model
Roles in process management
Strategic and operational process management
Process management, organizational environment and process models
Preparing, conducting and leading process workshops
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Operational process management (approx. 4 days)
Operational process management cycle
Deriving operational process goals
Process-oriented organizational development
Systemic order clarification
Develop target processes
Introducing, executing, measuring and analyzing processes
Change management during process rollout
Dealing with resistance and conflicts
Process model "Introduction of BPM"
Introduction of OPM (practical examples)
Strategic process management (approx. 3 days)
Defining goals
Use process-oriented balanced scorecard
Developing a process map
Plan and control processes strategically
Integrate strategic and operational process management
Process-oriented organization (approx. 4 days)
Challenges in the design of the process-oriented organization
Setting up BPM governance
Forms of the process-oriented organization
Designing a process model
Aligning technology with processes
Integrating existing methods
Leading a process-oriented organization (approx. 4 days)
Challenges in managing the process-oriented organization
Introducing and implementing role concepts for process and line
Deriving competencies from processes
Establishing a learning organization
Accompanying change with process-oriented organizational development
Procedure models for the introduction of the process-oriented organization
Promoting a process-oriented culture
Leadership in the process-oriented organization
Project work, certification preparation and certification examination "Process 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
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
Changes are possible. The course content is updated regularly.
With project and process management skills, you will be able to understand extensive projects and complex processes in their entirety. After the course, you will not only have basic project management techniques and be able to apply them with software support (MS Project), but you will also be familiar with approaches, process models and systems to make processes even more successful. You are also familiar with the requirements of a GMP system and know which regulations must be applied, can use them for your own problems and understand and explain specific technical terms. You will also be able to implement Six Sigma projects independently and successfully in accordance with ISO 13053-1:2011-09 and apply the specific tools and methods with confidence, enabling you to implement complex improvement projects responsibly.
The course is aimed at science students, engineering graduates, production managers and quality assurance officers as well as all employees in pharmaceutical production, technology, quality control and quality assurance, and all persons who are responsible for compliance with "Good Manufacturing Practice" and wish to acquire the relevant knowledge.
Knowledge of project and process management as well as Six Sigma as an internationally standardized and recognized method of quality management and process improvement in combination with GMP knowledge prepares you well for project and process management in the production of pharmaceuticals and active ingredients, but also in 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).