GDP Basic – manufacturing

Learn the basics of GDP (Good Distribution Practice) with our interactive e-learning course - when it suits You and Your training plan!

Use the course as an introduction to GDP if You are new in Your role, or as an annual GDP refresher to ensure Your knowledge compliance according to authority requirements.

Target group

For You who are affected by GDP in Your role within manufacture of medicinal products according to GMP and need basic knowledge of the distribution of medicinal products in accordance with GDP. The course is perfect if You are new in Your role or if You need an annual refresher training on a basic level.

Not in the target group?
If You are affected by GDP in Your role within Quality Assurance, Quality Control, Regulatory Affairs, Pharmacovigilance, Medical Information, Supply Chain or Marketing at a pharmaceutical or wholesaler company, we recommend that You take the web course GDP Basic.

If You work within transport of pharmaceuticals, for example as a driver, we recommend our web course GDP Basic – transport.

If You are part of the company management team, You will find what you need to know on a basic level in our shortened course GDP Basic – management team.

These four courses are built around the same content and follow the very same structure. If You have several roles within the company, You only need one of the above courses. If You are unsure of which one to choose, please contact us for advice!

Training goals

After completing the course, You will have:

• knowledge of existing rules and guidelines relating to GDP
• an understanding of how medicinal products are distributed according to GDP

Course contents

The course covers the following topics:

• Background and regulatory framework
• Requirements for wholesale authorisation
• Quality system
• GDP through the distribution chain
  - Certificates, country of manufacturing and traceability
  - Distributor's procedures
  - In the warehouse
  - Transport and returns
  - Complaints and recalls
  - CAPA: correct amendment procedure
• Inspections & agreements
• Falsified medicines
• Closure and evaluation

Language

This course is held in English but is also available in Swedish and Finnish

Subject experts

The course has been developed in consultation with leading industry experts in the EU market.

Course completion and certificate

After registration, You have 6 months to complete the course. The course takes an average of 1–2 hours to complete depending on Your prior knowledge. After passing the test, You will receive a personal course certificate as documentation of completed course. Are there several people at your company taking the course? We recommend that You appoint a person to arrange a meeting to reflect on Your local implementation of the contents of the course. The course provides suggestions for reflection questions to start from.

Registration

Please register to the course by clicking on the yellow button up to the right. The course will be made available after payment and for 6 months. Use browser Google Chrome to complete the course.

Price

Single licence: SEK 2 750 per licence
Group licence for 10–40 persons: SEK 2 100 per licence (choose the option "multiple enrolments" when registering. The booking confirmation will show the regular price of SEK 2 750 per licence, but the price is adjusted to SEK 2 100 per licence before the invoice is sent out.)

When purchasing more than 40 licences, please contact Sandra Trost, sandra.trost@lakemedelsakademin.se, for price and instructions.

Contact
For questions about the contents: Sandra Trost, sandra.trost@lakemedelsakademin.se