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  COURSE 5

GMP Refresher (GMP-R)



Target Group

Staff who work in a facility that manufactures pharmaceuticals or active pharmaceutical ingredients.

Prior Knowledge:
Some prior GMP knowledge is required.

Languages available:
Dutch, German, English and Danish.

Implementation:
Using videos from GMP facilities!

Study Time:
3.5 hours

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

BOOK THIS COURSE (190 €)

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.


Details

Text, image and video-based case studies are shown in seven modules. Different situations are also shown from the application of medicinal products to patients and from the operational environment - both from drug production and active ingredient production - which relate to GMP or GMP deficiencies.

In each situation, questions on the understanding of GMP are asked at different points and must be answered by the user straight away. The right solution is directly shown to the user and then explained in detail using words, images and video.

Each module finishes with a topic-related multiple choice test consisting of 10-30 questions.

Certificate
Attendance certificate from CONCEPT HEIDELBERG

Costs - individuals
€ 190,- 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.

Topic 1: Why GMP?

    Importance of GMP
    Contamination
    Damage
    Mix-ups
    Micro-organisms
    Disinfection
    Procedures
    Checking
    Test

Topic 2: Validation

    URS
    IQ, OQ, PQ
    Validation team
    Training
    Documentation
    Change Control
    Revalidation
     

Topic 3: Change Control

    Changes
    State of Control
    Testing
    Validation
    Documentation
    CC Procedure
    Test

Topic 4: Deviations

    Procedures
    Batch record
    Notations
    Being critical
    Double checking
    Reporting
    Test

Topic 5: Maintenance

    Validation
    Changes
    Procedures
    Signing in and out
    Clothing
    Documentation
    Writing mistakes
    Checking
    Test

Topic 6: Cleaning

    Procedure
    Cross contamination
    Order
    Refreshing cleaning water
    Clothing
    Production
    Cleaning up, disposing
    Washing hands
    Test

Topic 7: Administration

    Documentation
    Locking
    Pass words
    Checking
    Audit trail
    Changes (IT)
    Updates (IT)
    Test
     

BOOK THIS COURSE (€ 190)