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Certificates: Certificate "IPMA® Level D - Certified Project Management Associate from PM-ZERT"
Certificate "Quality representative with TÜV Rheinland-certified qualification"
GMP - Good Manufacturing Practice" certificate -
Examination: Praxisbezogene Projektarbeiten mit Abschlusspräsentationen
Zertifizierungen durch die PM-ZERT, Zertifizierungsstelle der GPM Deutsche Gesellschaft für Projektmanagement e. V.
Qualitätsbeauftragte:r mit TÜV Rheinland geprüfter Qualifikation -
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 IPMA® Level D
Technical competencies (approx. 8 days)
Project design
Requirements and objectives
Scope of services and delivery objects
Procurement
Opportunities and risks
Agile project management
Stakeholders
Change and transformation
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Presentation options for project management using MS Project (approx. 10 days)
Introduction to MS Project
Process and deadlines
Organization, information and documentation
Project quality
Costs and financing
Resources
Planning and control
Competence area Personal and social skills (approx. 9 days)
Self-reflection and self-management
Personal integrity and reliability
Personal communication
Relationships and commitment
leadership
Teamwork
Conflicts and crises
Versatility
Negotiations
Result orientation
Competence area Context skills (approx. 3 days)
Strategy
Governance, structures and processes
Compliance, standards and regulations
Power and interests
Culture and values
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.
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)
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.
You have sound knowledge of project management - strategic, technical, personal and social skills, e.g. in communication, teamwork and feedback. You are also familiar with MS Project software.
You will also 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.
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.
Persons from the technical, design and/or commercial or office sector who are familiar with the planning, implementation and evaluation of projects or who aspire to such an activity.
The course is also aimed at managers and employees who are entrusted with quality management, who are to implement a QM system in practice or who would like to develop in the area of quality management.
Upon successful completion of the course, you will receive the "Certified Project Management Associate (IPMA® Level D)" certificate from PM-ZERT. The certification is based on the ICB® (IPMA Competence Baseline®). This provides a detailed insight into your newly acquired qualifications in the field of project management and thus facilitates your career entry and advancement.
An additional qualification in quality management is in demand from companies of all sizes in industry, trade and the service sector. After the course, you can provide meaningful proof of your new skills with a TÜV Rheinland-certified qualification.
Additional GMP knowledge is indispensable in almost all areas of production and opens up numerous new opportunities for you.
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).