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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.
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
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
Part 1 finishes with a test (20 questions) that covers the previous 5 topics.
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
Study time: 1,5 to 2,5 hours
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
This course is intended to build on Part 1 and Part 2 using various case
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
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