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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
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.
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
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
Changes are possible. The course content is updated regularly.
You have solid knowledge of project management - strategic, technical, personal and social skills, e.g. in communication, teamwork and feedback.
You will also be able to plan, introduce and maintain a quality management system and monitor its effectiveness. You 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, the applicable regulations and the central processes of pharmaceutical quality management. You will understand the basics of SOP systems, CAPA, change management, audit processes, documentation, quality control, industrial hygiene and cleanroom requirements and be able to classify relevant technical terms with confidence.
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 as a quality officer 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).