Validation in the pharmaceutical industry

Overview

Kategorie Kategorie
Onsite Training, Workshops
Preis Preis
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Stephanie Kaiser
sepp.med academy

Everything important at a glance

What is the aim of the training - Validation in the pharmaceutical industry

This training course provides the necessary knowledge of the legal requirements and an insight into possible forms of implementation.

Pharmaceutical manufacturers are subject to strict legal regulations that are intended to exclude risks for end users and patients. The majority of the requirements relate to the development and production process. Among other things, the production process, and therefore all tools used (hardware and software), must be validated in the production environment.

Suppliers whose products are to be used in the pharmaceutical industry can support their customers with a suitable development process and standard-compliant documentation. This training provides the necessary knowledge of the legal requirements and an insight into possible forms of implementation.

 

Course content: What you will learn
  • Regulatory requirements and standards
  • Risk analysis and software classification
  • GAMP 5 V-model
  • Design Qualification
  • Verification in the development process (IQ/OQ)
  • Validation of production facilities (PQ)
  • Documentation and electronic signature
More Information
  • Seminar duration:
    3 days
  • Target groups:
    Project managers, quality managers, process managers
  • Number of participants:
    maximum 10
  • Prerequisites:
    Basic knowledge of the development process desired
  • Certificate:
    Participants receive a certificate of participation
  • Costs:
    Price on request

Your trainers

Zurzeit sind leider keine Informationen zu den Trainern hinterlegt.

Suitable follow-up courses

Zurzeit sind leider keine weiteren Trainings hinterlegt.

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    Foto von Stephanie Kaiser
    Your contact
    Stephanie Kaiser
    sepp.med academy