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10th GMP Training - The Complete GxPerience

This training consists of two parts:

  1. A GMP Basic Training on Pharmaceutical Quality Management Systems containing a Cleanroom behaviour trainingGMP
  2. A GMP Advanced Training on Aseptic / Sterile Manufacturing in Cleanrooms.
    The training is given in the Training Center with demo Cleanroom Facilities of Advipro in Lille (Turnhout).

Program

Registration

The GMP Basic Training (morning session) targets professionals in the (bio)pharmaceutical industry, regulatory, logistics, administrative function who want to learn the basics of Good
Manufacturing Practices. This session will continue with the classification of a Cleanroom and a Cleanroom Behaviour Training.

The GMP Advanced Training (afternoon session) targets professionals who want to get a deeper knowledge of the concepts and regulations of aseptic / sterile manufacturing.
This training will focus on contamination (source – microbiology), cleaning and desinfection and cleanroom gowning with practical exercises.

It is possible to follow only the basic session in the morning or advanced session in the afternoon.

Location:

The GxP Academy of Advipro
Wechelsebaan 143 – Unit 13 – 2275 Lille (Turnhout)

Date: Tuesday 11th June 2019

Start Time: 09:00 am - End time: 17:30

Price (lunch & drinks included ) :

250€ for a half-day and 400€ for a full day (VAPI-UPIP Member )
355€ for a half-day and 505€ for a fullday (non-Member, includes membership)

Registration has to be confirmed before 1st June 2019
Number of participants: max 25

A training certificate is provided to all participants at the end of the training.

Program

08:30 Welcome, Registration & Coffee

09:00 Start of Basic Production GMP training (1h30)

  • Definitions, legislation and different regulatory bodies.
  • GMP in a production process and quality management systems (e.g.Deviations, CAPAs, Change Control,…)

10:30 Break

10:45 Cleanroom – working and classification according ISO14644 vs Eudralex Vol 4 (45 min) Basic principles on functioning of a cleanroom and classification

11:30 Cleanroom Behaviour Training (1h15)

  • Theoretical behaviour + hygiene and gowning priniples (+ movies on gowning)

12:45 Lunch

13:45 Cleanroom – Contamination (sources and microbiology) and cleaning and desinfection (1h30)

  • Why working aseptically, types of contamination and sources
  • Microbiology
  • Cleaning and disinfection: definitions and good practice

15:15 Break

15:30 Cleanroom – Gowning and practical exercises GMP (1h30)

  • Practical exercises on gowning, washing hands,…

17:00 Q&A & Wrap-up

17:30 End of Training

Registration

 

UPIP-VAPI Timeline 2019

Read more 


TIMELINE 2019 UPIPVAPI WEB


 

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