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NEW OPEN Training: GMP mid-level, April 30th & May 1st 2019

Swiss Biotech Center is pleased to organize this year a series of training sessions for professionals in collaboration with Biotech Training Facility, a well-known training organization in the Netherlands. These sessions will take place at the BioArk technology site in Monthey (Switzerland). Discover the program of our upcoming GMP mid-level session and register now!

 

The kickoff for this series of training sessions is a 2-day GMP mid-level training course, from April 30th to May 1st  2019. The training’s program has been optimized for small-sized group and contains theory as well as practice, plus an exclusive visit of the Swiss Biotech Center facility! It’s ideal for professionals who want or need to know more about GMP (such as QA/QC) and operations staff performing GMP activities and looking for continuing training.

 

Short description of the training

A solid GMP training is a basic requirement for working in the pharmaceutical industry. With a very efficient and practical method given by Biotech Training Facility, you will learn the basics of GMP.

Theory and practice go hand in hand during this course, which enables the participants to put all acquired knowledge and skills immediately into practice.

 

Objectives

Increased awareness and knowledge of the following topics:

  • Basic principles of GMP
  • History of GMP legislation
  • Basic elements of various quality systems in pharmaceutical companies, including Out of Specification (OOS), deviations, change control, GMP documentation, outsourcing of work and process validation
  • GMP requirements for equipment and facilities
  • Basic principles of risk analysis within the pharmaceutical industry
  • Data integrity rules
  • Basics of microbiology and contamination control
  • Performing environmental monitoring
  • Basic principles of GMP within a QC laboratory

 

Target group

Anyone who wants or needs to know more about GMP, such as QA, QC, and operations staff who perform GMP activities. The training is limited to 12 participants (2 trainers)

 

PROGRAMME

Day 1 | April 30 Start time : 8:30 | End time : 17:00
Theory

  • Introduction to GMP history, legislation and basic principles
  • Quality systems within the pharmaceutical industry, including
    – Deviations
    – Change control
    – Training
  • Deviations and Out of Specifications
  • GMP documentation
    – Basic principles
    – Importance of GMP documentation
  • GMP facility and equipment
    – Qualification of facilities and equipment
    – Calibrations
    – Labelling of equipment
    – Preventing (cross) contamination
  • Data integrity, including:
    – Importance of data integrity
    – ALCOA principles (Attributable, Legible, Contemporaneous, Original and Accurate)
Pratice

  • Tour of Swiss Biotech Center GMP cleanrooms
  • Making a buffer while GMP activities are being simulated, including:
    – Following a batch production record
    – Filling in a batch production record
    – Use of raw materials
Day 2 | May 1st Start time : 8:30 | End time : 17:00
Theory

  • QC activities
    – Role of QC
    – Documentation related to QC labs, such as specifications
    – Reagents
    – Reference standards
  • Outsourcing of pharmaceutical activities
  • Change control
  • Risk assessment within the pharmaceutical industry
    – Basic principles of ICH Q9
    – FMEA technique (Failure Mode Effect Analysis)
    – Risk ranking
  • Contamination control, including:
    –  Basic principles of microbiology
    –  How to avoid microbial contamination of the product ?
Pratice

  • Workshop: a risk assessment is performed in order to determine the risks in case of a production/material change
  • Perform environmental monitoring tests

 

SESSION OVERVIEW
Start time : 30.04.2019
End time : 01.05.2019
Language : English
Cours fee : 2,500 CHF
Places available : max. 12
Location : BioArk Monthey (CH)
Enrollment deadline : April 2nd 2019

 

INSCRIPTION  & INFORMATION

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