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Certificates: GMP Auditor" certificate
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Additional Certificates: Certificate "Quality representative with TÜV Rheinland-certified qualification"
GMP - Good Manufacturing Practice" certificate
Certificate "Quality auditor with TÜV Rheinland certified qualification" -
Examination: Practical project work with final presentations
Quality officers with TÜV Rheinland-certified qualifications
Quality auditor with TÜV Rheinland certified qualification -
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: 12 Weeks
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
Quality auditor with TÜV Rheinland certified qualification
Fundamentals of auditing, audit types (approx. 2 days)
Audits as a management tool
Audit classification according to participants
Audit classification according to the subject of the audit
Standards as a basis for auditing and certification (approx. 1 day)
Industry-independent certification standards
Industry-specific certification standards
Management of an audit program (approx. 2 days)
Defining the audit program objectives
Audit program risks and opportunities
Defining, implementing and monitoring the audit program
Reviewing and improving the audit program
Carrying out an audit (approx. 3 days)
Initiating the audit
Preparing the audit activities
Carrying out audit activities
Creating and distributing the audit report
Concluding the audit
Carrying out audit follow-up measures
Competence and assessment of auditors (approx. 1 day)
Determining the competence of auditors
Determining the assessment criteria for auditors
Selecting the appropriate assessment method
Carrying out the auditor assessment
Maintaining and improving auditor competence
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Certification (approx. 1 day)
ISO 9001: A model for success
Certification - Why?
Selection of the certification company
Certification process
Process requirements for certification (approx. 3 days)
Activities prior to certification
Planning audits
Initial certification
Conducting audits
Certification decision
Maintenance of certification
Appeals, complaints
Customer records
Audit communication (approx. 2 days)
Basics of communication
Audit opening
During the audit
After the audit
Project work, certification preparation and certification examination "Quality auditor with TÜV Rheinland certified qualification" (approx. 5 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 are applied and be able to use them for your own problems as well as understand and explain specific technical terms. You will also learn the basics of the CAPA system and be able to plan, introduce and maintain a quality management system and monitor its effectiveness. You will also have professional knowledge of the application of DIN EN ISO 9001 as well as all the necessary theoretical principles for the practical implementation of audits.
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", who wish to acquire the relevant knowledge and work as an auditor.
GMP knowledge combined with a good knowledge of quality management and the ability to plan and carry out audits are essential in almost all areas of the manufacture of medicinal products 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.
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).