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Certificates: GMP Production Coordinator" certificate
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Additional Certificates: GMP - Good Manufacturing Practice" certificate
Certificate "IPMA® Level D - Certified Project Management Associate from PM-ZERT"
Original SAP user certificate -
Examination: Praxisbezogene Projektarbeiten mit Abschlusspräsentationen
Zertifizierung durch die PM-ZERT, Zertifizierungsstelle der GPM Deutsche Gesellschaft für Projektmanagement e. V.
SAP-Anwenderzertifizierung UC_PP_S42022 -
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
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
Project Management IPMA® Level D
Artificial intelligence (AI) in project management (approx. 2 days)
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. 14 days)
Project design
Agile project management
Organization, information and documentation
Stakeholders
Opportunities and risks
Requirements and goals
Scope of services and delivery objects
Process and deadlines
Resources
Costs and financing
Planning and control
Personal and social skills (approx. 7 days)
Self-reflection and self-management
Versatility
Relationships and commitment
Personal integrity and reliability
Negotiation skills
Teamwork
Conflicts and crises
Leadership
Focus on results
Context skills (approx. 1 day)
Compliance, standards and regulations
Culture and values
Technical skills (approx. 2 days)
Change and transformation
Procurement
quality
Project work, certification preparations and certification exams in project management (approx. 10 days)
By PM-ZERT, certification body of the GPM Deutsche Gesellschaft für Projektmanagement e. V.
SAP User Production Planning (PP)
S4H00 SAP S/4HANA Overview (approx. 3 days)
Overview of SAP S/4HANA
Navigation, SAP Fiori, SAP Business Client, SAP Logon
System-wide concepts with organizational units, master data and transactions
Overview of financial accounting and logistics modules, mapping of the respective processes in SAP
Reporting, system structure and migration
SAP service offerings
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
S4210 Basic data for production and product management (approx. 7 days)
Master data for production
Material, parts lists, work centers, routings
Extended parts list functions
Extended routing functions
S4200 Business processes in SAP S/4HANA Manufacturing (approx. 7 days)
Overview of supply chain planning
Master data, sales planning, program planning, material requirements planning
Overview of the execution of production
Manufacturing with production orders
Manufacturing with process orders
Production with repetitive manufacturing
Material provision via Kanban
Project work/case study, certification preparation and SAP user certification for production planning (approx. 3 days)
Changes are possible. The course content is updated regularly.
After this course, you will be familiar with the requirements of a GMP system, know which regulations must be applied and be able to use them for your own problems as well as understand and explain specific technical terms. You are familiar with the basics of the CAPA system. You will also have a sound knowledge of project management and learn the key elements of production planning with SAP.
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.
GMP knowledge and a good knowledge of production planning and coordination are 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.
Training partner of SAP® Germany
In cooperation with the SAP training partner alfatraining Bildungszentrum GmbH, we will qualify you for a job in industry and business.
You are directly connected to the SAP® Germany servers and learn on the original SAP® training system (IDES) in the latest version. This gives you the necessary practical experience during the course.
All SAP user courses also conclude with the original SAP certification. Our SAP instructors are qualified SAP consultants who will provide you with intensive support and prepare you optimally for the certification exam.
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 teaching 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).