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GMP for Beginners in Sterile Manufacturing

: 8 Oct 2019 - 9 Oct 2019

: Berlin, Germany

Sector: Pharmaceutical

Type: Training


Objectives

The course is designed for people working in sterile manufacturing who have no or little knowledge of GMP. 

  • Get to know the most important pharmaceutical regulations for sterile manufacturing and their importance,
  • Get a basic overview of general GMP requirements and specific requirements in sterile manufacturing and
  • Become familiar with the most important basic processes in sterile pharmaceutical production

Programme

  • Introduction – What is specific for sterile manufacturing?
  • Regulations for sterile manufacturing
  • Microbiological basics
  • Clean rooms and Barrier Systems
  • Specific training requirements for sterile manufacturing
  • Cleaning and disinfection
  • Hygiene
  • Sterilisation processes
  • Involvement of the microbiological lab
  • Environmental monitoring
  • Media Fill
  • Handling failures in sterile manufacturing
  • Inspections / Audits / Observations
  • Workshop - Entering the clean area

Target Group

This course is aimed at those who are new to sterile manufacturing.

Find out more

 

Venue

Berlin
Germany


Organizer

ECA Academy
Phone: +49 (0)6221 84 44 0
Email: info@gmp-compliance.org
Visit: https://www.gmp-compliance.org/training


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Good Manufacturing P...
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Pharmaceutical Clean...