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  COURSE 1

GMP Basic Training Pharma



Target Group

Become aware of GMP

Target group:
Staff who work in a pharmaceutical production facility in the areas
  • Solid forms
  • Liquid forms
  • Sterile medicinal products.
Prior Knowledge:
No prior GMP knowledge is required.

Languages available:
Dutch, German, English, French, Italian*, Spanish, Danish, Swedish*, Portuguese*, Romanian and (Mandarin) Chinese.

Examples:
Using videos from GMP facilities!

Study time:
4-5 hours (*short version of approx. 3 hours)
Parts 1, 2 and 3 each 1-1.5 hours


Questions at:
Phone: +49(0)6221 / 84 44 0 - e-Mail: info (at) concept-heidelberg.de

BOOK THIS COURSE (€ 230)

BOOK Part 1 (€ 90)

BOOK Part 2 (€ 90)

BOOK Part 3 (€ 90)

WATCH DEMO

Do you want to book this course for more than 10 employees?
Send us an inquiry with the title of the course and the number of participants. We will make you a special offer.


Description

This interactive course will explain the basic principles of Good Manufacturing Practice. The focus lies on GMP topics that staff can influence themselves, e.g. contamination, mix-ups and damage.
Typical case studies are shown in the video and are interrupted by questions so the participants see real practical examples and are interactively involved using questions and answers.
The questions and answers are purely intended for the transfer of knowledge, i.e. it is perfectly ok and expected that questions will be answered incorrectly. If the question is answered incorrectly, the correct answer is revealed. The questions must only be answered correctly during the final test.

Certificate
Attendance certificate from CONCEPT HEIDELBERG

Costs - individuals
Part 1: € 90,- plus VAT
Part 2: € 90,- plus VAT
Part 3: € 90,- plus VAT
All 3 parts: € 230,- plus VAT

Costs - company licence
Companies which yearly train more than 50 employees can aquire a company licence. Depending on the use, courses can be carried out for under € 30,- per training hour.

BOOK Part 1 (€ 90)


Part 1
In Part 1 the emphasis lies on the principle: 'need to know'. The trainee has to give his/her opinion about several practical cases. This stimulates the trainee to become aware of GMP. The emphasis lies on coming to a GMP attitude (not on hammering in procedures or confronting the trainee with the GMP regulations).
Part 1 finishes with a test (20 questions) that covers the previous 5 topics.
    Why GMP?
    What is GMP?
    Threats of the quality
    Contamination and preventing it
    Mix-up and how to avoid it
    Damage and how to prevent it
    The need for checks
    Documentation and what it requires
    Test

Study time: 1,5 to 2,5 hours


Part 2
Part 2 shows the main issues of the SOPs concerning protective clothing, cleaning, warehouses, laboratories and clean areas. The approach is 'drill and practice'. Specific SOPs can be linked to this.
    Protective clothing + test
    Cleaning + test
    Warehouse + test
    Laboratory + test
    Clean areas + test
     

Study time: 1,5 to 2,5 hours

BOOK Part 2 (€ 90)


Part 3
This course is intended to build on Part 1 and Part 2 using various case studies.
    16 general GMP situations in production, packaging, storage and maintenance
    3 cleaning situations
    5 cleanroom situations

    Part 3 makes the trainee GMP-aware. Practical cases are shown and the trainee 'reacts' when something goes wrong. If the reaction is too late, the consequences are being shown to the trainee and he/she will receive extra information.

    Part 3 is comprised of a combination of tests and learning. The focus lies on becoming aware of incorrect GMP situations and reacting to them. Study time: 1 to 1.5 hours

Study time: 1 to 1,5 hours

BOOK Part 3 (€ 90)