GMP
Training courses

Tailored to your needs!

Adapted to your requirements
On site or online
GxP - & Business Trainings

Training and further education with the EI Academy

Bring your team up to date with your business! Get ahead with us!

WHAT EXACTLY DOES THE ACADEMY OFFER?

Flexible, whatever training you need at the time:

Basic knowledge for new employees, training courses on a specific topic, practical seminars lasting several days or short training courses on demand.

And the implementation is also flexible! Whether individual training units or a series of training courses that build on each other over many years:

Training formats

In-house training or qualification courses:

Training courses designed exclusively for a specific group of participants and tailored to the processes and requirements of your company.

On-demand learning platform:

Learn-anywhere-anytime! Flexible and simple training with short learning units.

GMP-Shorties (90-120 min.):

Short formats that convey the “basic facts” on a topic.

Practical seminars

Special events with a lot of practical relevance, special events and/or involvement of cooperation partners.

Solve your challenges with customized concepts – tailored to the size of your company

Small, medium-sized and large companies require different strategies to realize their GMP and GxP compliance. Get ahead with GxP Solutions.

Possible topics & training courses:

Training catalog

BASIC TRAINING COURSES ON GMP & ISO

RESEARCH & DEVELOPMENT

GMP for IMPs and I-ATMPs
GMP in clinical development

KEY POSITIONS

The person technically responsible for medicinal products
The LifeCycle Manager for pharmaceutical production

AUDITING

Auditing of service providers and ISO companies
Auditing of pharmaceutical manufacturers
Training as a GMP auditor

STORAGE, DISTRIBUTION & TRANSPORTATION

GDP for wholesale and logistics
GDP in Switzerland
GDP and GTP Germany
GMP in supply chain management
GMP in warehousing and logistics

UTILITIES

GMP for gases, compressed air & liquid media
Water “compact”

QUALITY MANAGEMENT & ASSURANCE

Data management and data integrity
GMP-compliant documentation and administration
Management Review
PQR and APR
Quality Oversight
Axle softening and CAPA
Application of risk analyses in the GMP environment
Supplier qualification
Cleaning validation
GMP basic knowledge technology
Process validation
Auditing of service providers and ISO companies
Training as a GMP auditor
Auditing of pharmaceutical manufacturers
Batch Record Review
The corporate GMP quality system
Change control and life cycle management (ICH Q12)
Train the Trainer
Risk management practice

REGULATORY WORKS

FDA regulations
Pharmacy for non-pharmacists
GMP regulations

COSMETICS, FOOD, MEDICAL PRODUCTS, EXCIPIENTS, PACKAGING MATERIALS

GMP for manufacturers of excipients
GMP for medical devices
Quality Assurance Expert Excipients- english

PURCHASING & PROCUREMENT

GMP in purchasing & procurement

COMPUTERIZED SYSTEMS

Computer system validation in the GMP area

TECHNOLOGY

GMP in plant engineering
GMP in maintenance & calibration
GMP basic knowledge technology
Modern methods of qualification / requalification
Welding in a GMP environment
Basic technical knowledge for quality assurance & auditors

MANUFACTURE

Clean rooms compact
GMP in packaging

GMP-SHORTIES (90-120 min.)

GMP for investigational medicinal products
GMP Benchmark: IMPs vs. IATMPs
Good Distribution Practice (GDP) for pharmaceutical wholesale, logistics, forwarding
Good distribution practices (GDP) in Switzerland
Good distribution practice (GDP) for medicinal products and active pharmaceutical ingredients
Tasks of the head of production
Current data integrity
Contamination Control System
GMP Corporate Quality System
Management Review
Supply Chain Management
GMP Quality Oversight: What it really means
Quality agreements in the GMP/GDP environment
The Qualified Person (QP) and Annex 16
Planning of clean rooms (Part I)
Components in the planning of clean rooms (Part II)
Clean rooms / GMP zone concept (Part III)
GMP technology: What is it?
Basics of sanitary design – avoiding contamination
Hygiene in technology
Biofilms: Formation and development
Water compact – regulations and explanations

PRACTICE SEMINARS

Lyophilization compact
Modern bottling
Practice of modern measurement technology
The practice of ultrapure water

QUALIFICATION COURSES

GMP Deviation Manager
The new Annex 16
GMP for hygiene service providers
The GMP Specialist Part II
Knowledge management in GMP operations
Change Control Manager
Qualification engineer
GMP Engineer
GMP auditor
Risk Manager
The GMP supervisor (within the department, group or management level)
Maintenance engineer
Specialist for GMP media systems

Experts Institute

Added value

Security

Compliance and regulatory
Security

Increased efficiency

Im Rahmen von Qualität, Umsatz und
Kosten

State of the art

Erprobte und digitale Lösungen, auf der Höhe der Zeit für Ihren Erfolg

1 step ahead

Staying ahead of the competition and strategically

Contents of training and further education
Free choice of formats: In-house or online
Length of training: short seminar or one-day event
Certified training & further education
Certificate of participation
Knowledge check at the end of the training
Qualified trainers with practical experience
Different modes of training possible (e.g. interactive workshop, inductive or dynamic training or solution-oriented training)
Sustainable coaching program possible
Language of the seminar freely selectable: German or English
Multicultural (specialist) training in global companies
Flexible response to the needs of individual participants

Contents of training and further education
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WE ARE

Uncomplicated and solution-oriented
Sustainable and empathetic
digital and agile
working where and for what we are needed

WE WILL

Building excellence and passing it on to our customers
Deliver high-level results
Achieving compliance and efficiency

WE DELIVER

personal integrity
Customized and feasible solutions
Meeting at eye level

Experts Institut
Projekte

On the road for you worldwide!

Collaboration is that simple

Contact request

Let us know your personal request using the contact form

Initial consultation

Get to know your contact person in a non-binding initial consultation

Briefing

You will receive an individual offer based on your briefing

Strong partner

Rely on a strong partner at your side during your project

Get in touch with us!

Claudia Teupe

Head of Administration

Your personal contact for everything to do with auditions

Neustadt

Experts Institut Beratungs GmbH
Kirchwiesenstrasse 5

D-67434 Neustadt a. d. Weinstraße

Phone: +49 (0)6321 969210
E-mail: info@expertsinstitut.de

Fax: +49 (0)6321 9692199

Bamberg

Experts Institut Beratungs GmbH
Untere Sandstraße 53

D-96047 Bamberg

Phone: +49 (0)951 51939330
E-mail: info@expertsinstitut.de

Freiburg

Experts Institut Beratungs GmbH
Habsburgerstrasse 101a

D-79104 Freiburg im Breisgau

Phone: +49 (0)6321 9692120
E-mail: info@expertsinstitut.de

St. Gilgen (Austria)

Experts Institut Beratungs GmbH
Helenenstrasse 16

A-5340 St. Gilgen, Austria

Tel.: +43 (0)6227 21068
E-mail: info@expertsinstitut.de

GMP Training courses