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  COURSE 3

GMP Basic Training API



Target Group

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

Prior Knowledge:
No prior GMP knowledge is required.

Languages available:
German, English, French, Dutch, Spanish, Danish and Swedish.

Implementation:
Using videos from GMP facilities!

Study Time:
Approx. 3 hours
(Part 1 approx. 1 hour, Part 2 approx. 0.5 hours and Part 3 approx. 1.5 hours)

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

BOOK THIS COURSE (€ 190)

BOOK Part 1 (€ 75)

BOOK Part 2 (€ 60)

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.


Details

Certificate
Attendance certificate from CONCEPT HEIDELBERG

Costs - individuals
Part 1: € 75,- plus VAT
Part 2: € 60,- plus VAT
Part 3: € 90,- plus VAT
All 3 parts: € 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.

Part 1

This part will show the basics of Good Manufacturing Practice in a facility that manufactures active pharmaceutical ingredients. A general introduction on the meaning of GMP will be followed by an explanation of what measures must be taken in order to prevent contamination during the manufacturing process. The basics of cleaning and hygiene will be clarified along with the dangers of contamination in machines and equipment, how to prevent this and the correct procedure for handling contaminated raw materials. Furthermore, examples are used to demonstrate the correct identification of raw materials, maintaining order and cleanliness as well as the importance of concentration in the workplace to avoid mix-ups. The section “Further quality defects” will demonstrate the significance of maintenance and calibration, validation, GMP-compatible documentation, reviews and process control. The different video sequences will feature scenes showing behaviours that do not conform to GMP and which need to be identified by participants. This part ends with a test consisting of 38 questions.

    Introduction of GMP
    What is the meaning of GMP and Q7?
    Cleaning areas and equipment
    Purity of raw materials
    Identification of production components
    Order and Cleanliness
    Working Attentively
    Maintenance
    Validation
    Documentation
    Quality control
    Processing
    Test

Study time: approx. 1 hour

BOOK Part 1 (€ 75)


Part 2

This part explains important rules for GMP-compatible documentation in the workplace and uses examples to clarify the great importance of observing regulations in all operational GMP areas. A whole section is devoted to batch sampling as an important procedure in GMP-regulated environments and shows GMP-compatible working. What characterises qualified staff in facilities that manufacture active pharmaceutical ingredients? This question is answered in the corresponding section of the module using various examples. GMP inspections occur often during everyday operational practice. The relevant section of the module explains the different types of inspection and demonstrates the correct behaviours in inspection situations. A test consisting of 18 questions can then be completed..

    Backgrounds of GMP
    Documentation
    Following Procedures & Instructions
    Taking Samples
    Quality Audits
    Qualified Personnel
    Test

Study time: approx. 0.5 hours

BOOK Part 2 (€ 60)


Part 3

This part consists of 3 sections, each showing one real-life example of which kind of errors can occur in different areas during production. A background story is outlined in several video sequences showing the course of events during a case of product contamination caused by GMP violations in different areas. This part contains scenes e.g. about batch sampling or from the field of production engineering that must be analysed for GMP errors. The inappropriate conduct of operational decision-makers as part of the fictitious “GMP accident” should also be recognised and listed.

    GMP-practical cases
    Problems during validation
    Mistakes during cleaning

Study time: approx. 1.5 hours

BOOK Part 3 (€ 90)