GMP (Good Manufacturing Practice) and SAP user Production Planning (PP)
Free of cost
by funding
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Certificates: GMP - Good Manufacturing Practice" certificate
Original SAP user certificate -
Examination: Practical project work with final presentations
SAP user certification UC_PP_S42022_EN -
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
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
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 will also be familiar with the basics of the CAPA system.
You will also be familiar with the main SAP applications in production planning and round off your professional profile with SAP user certification.
GMP knowledge is indispensable 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.
In addition, you will acquire the globally standardized and recognized SAP user certificate for production planning (PP). It is considered one of the most important manufacturer certifications in the commercial sector, with which you can improve your career prospects on the job market across all industries.
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).