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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
GMP - Good Manufacturing Practice" certificate
Certificate "Process manager with TÜV Rheinland certified qualification"
"Six Sigma Green Belt" Certificate -
Examination: Praxisbezogene Projektarbeiten mit Abschlusspräsentationen
Zertifizierung durch die PM-ZERT, Zertifizierungsstelle der GPM Deutsche Gesellschaft für Projektmanagement e. V.
Prozessmanager:in mit TÜV Rheinland geprüfter Qualifikation
Six Sigma Green Belt -
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
Artificial intelligence (AI) in project management (approx. 1 day)
Presentation of specific AI technologies
Recommendations for dealing with AI
Prompting in a professional context
Context skills (approx. 3 days)
Governance, structures and processes
Strategy
Power and interests
Personal and social skills (approx. 1 day)
Personal communication
Technical skills (approx. 10 days)
Project design
Agile project management
Organization, information and documentation
Opportunities and risks
Requirements and goals
Scope of services and deliverables
Process and deadlines
Stakeholders
Resources
Costs and financing
Planning and control
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.
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
Process manager with TÜV Rheinland-certified qualification
Basics of process management (approx. 2 days)
Understanding and terms in process management
Advantages of process management
Basic principles of process management
Benefits of process management
Components/characteristics of processes
Types of business processes (primary and secondary)
Structural/process organization
Strategic and operational process management
Overview of the most important process management methods: Six Sigma, Lean Management, BPR, Balanced Scorecard, PDCA and Kaizen
Artificial intelligence (AI) in the work process (approx. 1 day)
Presentation of specific AI technologies
and possible applications in the professional environment
Operational process management (approx. 8 days)
Operational process management cycle (process life cycle)
Methods of process identification and recording
Methods of identification such as SIPOC and IAO
Process landscape/map/process model
Structuring options for the process model
Methods of process mapping (from interviews to workshops) and storyboarding
Creativity in process management (e.g. mind mapping)
Methods and tools for process analysis
Methods and tools for process modeling and documentation
Modeling of flowcharts
Deriving operational process goals from strategic goals
Overview of management methods for optimization
Developing target processes from optimization
Change management during process rollout
Dealing with resistance and conflicts
Executing, controlling and monitoring processes
KPIs for process control and monitoring
Introducing CIP
Strategic process management (approx. 2 days)
Define corporate strategy
Determine goals and derive need for action, plan measures
Use KPIs
Define business model and structure
Use balanced scorecard
Plan and control processes strategically
Integrate strategic and operational process management
Process-oriented organization (approx. 4 days)
Challenges in the design and management of the process-oriented organization
Setting up BPM governance
Elements of BPM governance - from roles and documentation to process audits
Making the process model known
Aligning technology with processes
Roles in process management
Introducing and implementing role concepts for process and line
Leadership in the process-oriented organization: leadership skills, defining management processes, establishing learning organizations, promoting a process-oriented culture
Project work, certification preparation and certification examination "Process manager with TÜV Rheinland certified qualification" (approx. 3 days)
Quality Management – Six Sigma Green Belt
Introduction to Six Sigma (approx. 1 day)
What is Six Sigma? History, Philosophy, and Strategy
DMAIC Project Phases, Objectives, and Roles
Six Sigma in the Context of Lean, Quality Management, and Operational Excellence
Hybrid Project Management with DMAIC for AI Projects
AI-Powered Project Management (approx. 1 day)
Fundamentals of Artificial Intelligence
Applications Along the DMAIC Framework, Limitations, and Risks
Data and Prompt Fundamentals, Context, and Quality Criteria
Governance, Security, the EU AI Act, and the GDPR
AI Dashboard, Information Consolidation, and Quality Gates
Define – Define (approx. 3 days)
Project identification, strategic relevance, and key metric driver tree
Distinction from CIP and PUL (Problem, Cause, and Solution)
Project Profile: Problem Description and SMART Goal Definition
In-scope and out-scope definitions, as well as AI-supported completeness check
LIPOK and Voice of the Customer (VoC)
Affinity Diagram and Kano Model
VoC-to-CTQ transformation, specifications, and acceptance criteria
AI-supported analysis and technical validation of customer requirements
Cost-effectiveness: ROI, TCO, and qualitative benefits
Stakeholder Analysis and AI-Supported Project Planning
Risk Analysis and Preventive Measures
Change management and motivation for change
Communication strategy, elevator pitch, and AI-supported change story
Quality Gate Review: Define
Measure – Measurement (approx. 3.5 days)
Mathematical process model and cause-and-effect chain of the CTQs
Influence analysis using Ishikawa and KSR, as well as an AI-supported metrics matrix
Data Types and Measurement Scales
Operational definition, data collection methods, and sampling strategy
Data collection plan and control using an AI dashboard
Measurement system analysis: bias, repeatability, reproducibility, and gage R&R
Data quality, plausibility checks, and AI-supported data cleaning
Data Visualization, Statistical Metrics, and Machine and Process Capability
AI-Supported Interpretation of Measurement Results and Quality Gate Review Measure
Analyze – Analysis (approx. 3.5 days)
Process Map and Data Map, as well as Value Stream Analysis
Value stream analysis, spaghetti diagram, TIMWOODS, and Makigami
Distinguishing Between Symptoms, Problems, and Causes
Cause-and-effect and Pareto analysis, as well as AI-supported error code clustering
Hypothesis Formulation and AI as a Sparring Partner
Design of Experiments and AI-assisted testing of influencing factors
Correlation and regression analysis, as well as statistical hypothesis testing and group comparisons
AI-Supported Evidence Matrix and FMEA
Quality Gate Review and Analysis
Improve – Innovative Improvement (approx. 3 days)
Creativity Techniques and AI-Supported Solution Development
Lean solution principles as well as technical and organizational measures
Solution approaches using generative AI, automation, and robotics
Regulatory and organizational requirements for AI deployment
AI-specific risk assessment, as well as feasibility and maturity analyses
Solution evaluation
Acceptance and cost-benefit analysis
Implementation plan and pilot program with success and acceptance criteria
Iterative Approach to AI Pilots and Quality Gate Review Improve
Control – Controlling and Sustainable Implementation (approx. 2 days)
Go-Live, Process Stabilization, and Support During the Start-up Phase
Standard Operating Procedures and Controlling Plan
KPIs, statistical process control, control charts, and corrective actions
Balanced Scorecard and AI-Supported Monitoring
Audit Concept
Project completion, handover, and AI-supported documentation
Quality Gate Review Control
Project work, exam preparation, and final exam (approx. 3 days)
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, but you will also be familiar with approaches, process models and systems to make processes even more successful. You will also be familiar with the requirements of a GMP system and know which regulations must be applied, be able to 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 will prepare 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).