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GxP training and consulting

AURIGON GxP TRAINING AND CONSULTANCY SERVICES

Aurigon with its headquarters in Munich, Germany and Dunakeszi, Hungary, is working in compliance with the Good Laboratory Practice (GLP) since 2002. Since then the GxP regulated portfolio was expanded by the performance of batch release assays in compliance with Good Manufacturing Practice (GMP) and measurement of human samples from clinical trials in accordance with Good Clinical Laboratory Practice (GcLP) guidelines. Our quality system complies with national and international regulations and was approved by several sponsor audits and authority inspections.

Our QA experts have gathered broad experience and knowledge by establishing, maintaining and adopting permanently Aurigon´s quality system to fulfill on the one hand requirements of GxP regulations and laws and on the other hand Sponsors´ expectations.

Since we’re keen on sharing our expert knowledge, we established a new service in the field of GxP training (GLP, GMP for batch release assays, GcLP). Our clients will benefit from our comprehensive experience and get new insight into the GxP regulated environment.

The standard training program below can be adapted to our client´s special interests. In addition, special in-house training courses can be established depending on our clients´ specific questions.

The standard training program includes:

Basic GLP training

This training is composed to give a general overview on the basic GLP regulations. Examples from practice will complement the program.

  • history, background, scope, current international regulations
  • Organization and responsibilities
  • Study performance according to GLP
  • Quality assurance program
  • Standard Operating Procedures
  • Documentation and archiving
  • Handling of test items and test systems
  • Handling of equipment

GMP requirements for batch release assays

Batch release testing should be performed in compliance with Good Manufacturing Practice (GMP). This training is intended to provide information for laboratories that are not familiar with GMP but want to perform certain release tests. In this case they should develop a GMP compliant quality system and obtain GMP certification from the competent authorities. Our training program aims to help laboratories to achieve GMP readiness. The training includes:

  • Understanding GMP basics
  • What is the difference between GMP and GLP?
  • Deviation management
  • Corrective actions – Preventive actions (CAPA)
  • Handling out of specification results (OOS)
  • Site master file (SMF)
  • The role of the Qualified Person (QP)
  • Requirements for a GMP certificate

Special training courses

GcLP requirements for laboratories analysing clinical trial samples

  • Regulatory background
  • Requirements on the quality system
  • Practical implementation

Performance of audits at a GxP regulated CRO

  • Preparation, performance and reporting of an audit
  • Follow-up of audit findings
  • Responsibilities

Performance of GLP multi-site studies

  • GLP background and basics of GLP 
  • Challenges on the organisation of multi-site studies
  • Responsibilities

GLP/ GMP consultancy

This service offers our support for introduction of GLP/ GMP quality system at your laboratory and helps you through the certification process.

Who should attend the training and consultancy program?

The basic GLP training is relevant for those who wish to understand the requirements of current GLP regulations. It addresses to new employees who will work in a GLP regulated environment (e.g. study directors, technical personal, QA managers), as well as those who wish to refresh their knowledge.

Special training courses address to those who wish to learn a certain aspect of the GLP or GMP regulations or to those who are working with GLP regulated companies or contract research organizations (CROs).

Consultancy is useful for those who want to establish GLP/ GMP quality system in their laboratories, but do not have exact knowledge how to fulfill the relevant requirements.

Available languages:

 

German, English, Hungarian

 

In order to join this project, get in touch with us here or contact your Aurigon BD manager!

We are looking forward to discuss your needs and foster your knowledge a wing stroke ahead.


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