GMP – Basics

GMP – BasicsGMP Seminar Foto_klein

A common path to effective manufacturing practice.

In this seminar, our experts impart basic knowledge on GMP-relevant topics from the areas of production, quality control and quality assurance. Not only will you gain an overview of national and European GMP regulations (GMP guidelines, EU GMP guidelines), but you will also learn how to interpret and comply with the rules and requirements of good manufacturing practice and how to put them into practice. Alongside the basic GMP rules, we also address the important areas of documentation practice and operational hygiene.

TARGET AUDIENCE

All employees from the pharmaceutical industry (e.g. laboratory, production, quality control and engineering, administration). Previous knowledge is not required, but also not a hindrance!

CONTENT

Patient safety

  • Objective
  • History
  • Regulatory framework

Key requirements

  • “prospektive” requirements
  • Calibration – qualification – validation
  • “retrospective” requirements

Good documentation practice

  • Document types
  • Creation and control of documents
  • Data integrity (ALCOA principle)

Operational hygiene

  • Potential sources of contamination
  • Hygiene zones
  • Hygiene measures

FURTHER LANGUAGES

This seminar can be provided in Chinese (汉语) and Russian (по-русски) language, too.


DATE, TIME, PLACE

  • new appointments upcoming

SPEAKER

PRICE

  • 800 Euro (plus applicable taxes), incl. seminar food

REGISTRATION (Please, click “Register” below.)

CONTACT

In case of any questions regarding our seminar program, please do not hesitate to contact us:

Contact person Susan Ohlendorf
040 303874 44
training@gmplan.eu