GMP
Training courses

Tailored to your needs!

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

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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:

Contact us with your ideas and you will receive a customized solution.

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.

Possible topics and training courses:

BASIC TRAINING COURSES ON GMP & ISO

  • The GMP Specialist Part I
  • Project management
  • Auditor training ISO9001
  • ISO27001
  • Sustainability management
  • Business continuity management

AUDITING

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

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

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

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
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Projects in

  • Spain
  • Switzerland
  • Austria
2

USA

  • Training courses
  • Seminars
3

Mexico

  • Auditor training
4

Algerien & Marokko

  • Beratung zu Regelungen und Auswirkungen von Handelsabkommen

  • Beratung beim Aufbau des lokalen Beratungswesens
5

Ethiopia

  • Introduction of QA systems
  • Auditor training
6

Zambia

  • Food safety advice
7

South Africa

  • Food safety advice
8

Serbien Kosovo Albanien Mazedonien

  • Beratung Food-Safety & Certification
9

Romania

  • Training for a German automotive supplier
10

China

  • Advice on the more efficient use of resources in the food manufacturing industry
  • Training for a German automotive supplier
11

Phillipines

International introduction of ISO 22000

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

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