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GMP and GDP Training

Regular GMP and GDP training is an important part of every GMP/GDP-regulated company

Only by corresponding annual training of all relevant employees and a subsequent learning success control the requirements of the guidelines of the “Good Manufacturing Practice” or the “Good Distribution Practice” are fulfilled.

 

Ein Raum voller Menschen bei einer Besprechung.

Valicare GmbH supports you in this respect with on-line or in-house GMP basic training courses, and/or GDP basic training courses, which can last half a day or a whole day, depending on the desired intensity.

Valicare GmbH has extensive specialist knowledge to meet your individual needs. To optimize your training success, we can adapt the training material to your product range and integrate company-specific procedures and processes.

Our GMP training courses cover the following topics, which can also be trained as individual topics according to the special needs of our customers.

Our GMP training courses cover the following topics:

  • GMP Basics
  • GDP Basics

 

  • Overview of a basic training course or individual topics
    • Production and quality control
    • Clean room operation and technology
    • Hygiene Concepts
    • Documentation and data integrity
    • Risk management and analysis
    • Qualification and validation
    • Method and process validation
    • Computer system validation
    • GMP requirements for advanced therapy products (ATMPs)
    • Requirements for investigational medicinal products
    • Achievement of a manufacturing license according to §13 AMG
    • Conditions of import according to § 72 ff AMG
    • EN ISO 13485 & EN ISO 9001 compliance
  • GDP-relevant issues are in particular
    • Responsibility under pharmaceutical law
    • Supply chain security & counterfeit management
    • Outsourced activities: Storage and transport
    • Qualification and mapping of storage facilities
    • Validation of transports
    • Deviations and recalls
    • Export and import
  • Company and personalized GMP coaching

    We offer individual GMP coaching by our respective experts in preparation for a professional position in the pharmaceutical, biotechnology or ATMP manufacturing environment.

    For companies, GMP coaching for newcomers enable them to quickly familiarize themselves with relevant GMP topics. The scope of the training varies (1-3 days) depending on the desired GMP topics and depth of training. The training can be held on site, at Valicare in Frankfurt (up to 12 people) or virtually.

    Find an overview of our GMP/GxP basic training or individual training topics here.

We are pleased to extend these title lists to include your specific subjects. The conclusion of each training course is an anonymous success control, based on which each training participant receives a certificate for the successful participation. The training documents are either provided electronically as PDF sheets in advance or submitted to the training participants in paper form.

 

Contact us now and describe your training needs. In dialog, we will put together the perfect training package for your employees. You will receive our offer shortly after the interview. If you are still missing relevant training content, please let us know. We find a solution for you.

Ellen Sons Brinkmann

First consultation free- contact us now!

Dr. Ellen Sons-Brinkmann
Tel: +49 69 153 293 709
Mail.: ellen.sons-brinkmann@valicare.com