Qualitätssicherung in Medizin und Pharma

Overview

Kategorie Kategorie
Workshops, Onsite Training
Preis Preis
Auf Anfrage
Foto von Stephanie Kaiser
Your contact
Stephanie Kaiser
sepp.med academy

Everything important at a glance

What is the aim of the training - quality assurance in medicine and pharmaceuticals

This training course provides an overview of the relevant standards and laws and gives an insight into possible forms of implementation.

The requirements for quality assurance are becoming increasingly demanding, and not only for medical software. Pharmaceutical manufacturers are also subject to strict legal regulations that are intended to exclude risks for end users and patients. In both sectors, there are requirements for the development and production process, the motivation for which is not necessarily transparent to all developers and testers involved.

Course content: What will you learn?
  • regulatory requirements and standards
  • Basic philosophy
  • Process models
  • GAMP 5 V-model
  • Differentiation from GAMP 4 (IQ, OQ, PQ)
  • Risk analysis and software classification
  • Core processes of software development
  • SW testing methods
  • Basics of model-centered testing
  • Test management (test planning, partial testing, variant management)
  • 21 CFR Part 11
  • Usability
More Informatio
  • Seminar duration:
    4 days
  • Target groups:
    Software developers, software testers, project managers in medical technology and pharmacy
  • Number of participants:
    maximum 10
  • Prerequisites:
    Basic knowledge of the development process in medical technology and/or pharmacy desired.
  • Certificate:
    Participants will receive a certificate of attendance
  • Costs:
    Price on request

Your trainers

Zurzeit sind leider keine Informationen zu den Trainern hinterlegt.

Do you have any questions about our range of courses?

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