GMP
Schulungen

Tailored to your needs!

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

GMP training courses

Possible subject areas and training topics

Make optimum use of all possibilities
With Experts Institut, you can take advantage of all the possibilities that arise from the size of your company and organizational structure and overcome the limits you have reached.
Proven practical knowledge
Our interpretations of regulatory requirements and our risk-based approach have proven themselves many times over.
All-round GxP service
Take advantage of a broad portfolio: from training, GMP consulting and technical consulting to audits and inspections, you will receive customized concepts and support from experienced experts.

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.

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.

Training catalog

Mögliche Themen und Schulungen:

BASISSCHULUNGEN ZU GMP & ISO

Der GMP-Spezialist Teil I
Projektmanagement
Auditorentraining ISO9001
ISO27001
Nachhaltigkeitsmanagement
Business Continuitity Management

AUDITIERUNG

Auditierung von Dienstleistern und ISO-Betrieben
Auditierung von Pharmaherstellern
Ausbildung zum GMP-Auditor

FORSCHUNG & ENTWICKLUNG

GMP für IMPs und I-ATMPs
GMP in der Klinischen Entwicklung

SCHLÜSSELPOSITIONEN

Die Fachtechnisch verantwortliche Person für Arzneimittel
Der LifeCycle Manager für die pharmazeutische Produktion

LAGERUNG, DISTRIBUTION & TRANSPORT

GDP für Großhandel und Logistik
GDP in der Schweiz
GDP und GTP Deutschland
GMP im Supply Chain Management
GMP in Lager und Logistik

UTILITIES

GMP für Gase, Druckluft & flüssige Medien
Wasser „kompakt“

QUALITÄTSMANAGEMENT & -SICHERUNG

Datenmanagement und Datenintegrität
GMP-gerechte Dokumentation und Administration
Management Review
PQR und APR
Quality Oversight
Achweichung und CAPA
Anwendung von Risikoanalysen im GMP-Umfeld
Lieferantenqualifizierung
Reinigungsvalidierung
GMP-Basiswissen Technik
Prozessvalidierung
Auditierung von Dienstleistern und ISO-Betrieben
Ausbildung zum GMP-Auditor
Auditierung von Pharmaherstellern
Batch Record Review
Das Corporate GMP-Qualitätssystem
Änderungskontrolle und Life Cycle Management (ICH Q12)
Train the Trainer
Praxis des Risikomanagements

REGELWERKE

FDA Regularien
Pharmazie für Nicht-Pharmazeuten
GMP-Regularien

KOSMETIK, LEBENSMITTEL, MEDIZINPRODUKTE, HILFSSTOFFE, PACKMITTEL

GMP für Hersteller von Hilfsstoffen (Excipients)
GMP für Medizinprodukte
Quality Assurance Expert Excipients- english

EINKAUF & BESCHAFFUNG

GMP in Einkauf & Beschaffung

COMPUTERGESTÜTZTE SYSTEME

Computersystemvalidierung im GMP-Bereich

TECHNIK

GMP im Anlagenbau
GMP in der Instandhaltung & Kalibrierung
GMP-Basiswissen Technik
Moderne Methoden der Qualifizierung / Requalifizierung
Schweißen im GMP-Umfeld
Technisches Basiswissen für Qualitätssicherung & Auditoren

HERSTELLUNG

Reine Räume kompakt
GMP in der Verpackung

GMP-SHORTIES (90 – 120 MIN.)

GMP für Klinische Prüfarzneimittel
GMP Benchmark: IMPs vs. IATMPs
Gute Vertriebspraxis (GDP) für Pharmagroßhandel, Logistik, Spedition
Gute Vertriebspraxis (GDP) in der Schweiz
Gute Vertriebspraxis (GDP) von Arzneimitteln und Wirkstoffen
Aufgaben des Leiters der Herstellung
Datenintegrität aktuell
Contamination Control System
GMP-Corporate Qualitätssystem
Management Review
Supply Chain Management
GMP Quality Oversight: Was es wirklich bedeutet
Quality Agreements im GMP-/GDP Umfeld
Die Sachkundige Person (QP) und der Annex 16
Planung von Reinen Räumen (Teil I)
Komponenten bei der Planung von Reinen Räumen (Teil II)
Reine Räume / GMP-Zonenkonzept (Teil III)
GMP-Technik: Was ist das?
Grundlagen des Sanitary Design – Vermeidung von Kontaminationen
Hygiene in der Technik
Biofilme: Entstehung und Entwicklung
Wasser kompakt – Regularien und Erläuterungen

PRAXISSEMINARE

Lyophilisation kompakt
Moderne Abfüllung
Praxis der modernen Messtechnik
Praxis des Reinstwasser

QUALIFIZIERUNGSLEHRGÄNGE

GMP-Deviation Manager
Der neue Annex 16
GMP für Hygiene-Dienstleister
Der GMP-Spezialist Teil II
Knowlegde Management im GMP-Betrieb
Change Control Manager
Qualifizierungsingenieur
GMP-Ingenieur
GMP-Auditor
Risk Manager
Der GMP- Vorgesetzte (innerhalb der Abteilung, der Gruppe oder Managementebene)
Instandhaltungsingenieur
Fachkraft für GMP-Mediensysteme

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

YOUR REQUIREMENTS DETERMINE THE CONTENT OF THE TRAINING COURSE:
FOR YOUR TEAMS TO FOCUS ON YOUR PROCESSES AND CORE AREAS.
The regular training of your employees is the focus of our company. In order to address your needs in a targeted and relevant manner, we discuss all the necessary topics in a kick-off meeting, define a date and conduct an interactive training session.

Competent support

Our experienced speakers bring with them a broad spectrum of different industries and practical examples. This is reflected in a well-illustrated training course.

Interactive

Through workshops, practical examples and a confident manner, we switch from a pure lecture style to interactive training with your employees. This ensures successful learning.

Experienced – in all areas

You can rely on consultants with many years of experience – for internal and external audits in the GMP and ISO areas.

Including documents and certificate

Afterwards, you will receive a certificate from us confirming the training. The documents are also made available digitally – in printed form if required. Knowledge checks are also part of our Academy.

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 Schulungen