GDP Basic – management team
2,600 kr
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 affected by GDP in Your role within the management of, for example, a pharmaceutical company. As part of the company management, You have a central role in ensuring an effective quality system by following quality parameters such as deviations, changes and inspections, and ensuring that sufficient resources are allocated and that the staff has sufficient competence. 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 are involved in pharmaceutical manufacturing, we recommend that You take the adapted GDP Basic – manufacturing.
If You work within transport of pharmaceuticals, for example as a driver, we recommend our web course GDP Basic – transport.
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
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.
Price
Single licence: SEK 2,600 per licence
Group licence for 10–40 persons: SEK 1,950 per licence (choose the option "multiple enrolments" when registering. The booking confirmation will show the regular price of SEK 2,600 per licence, but the price is adjusted to SEK 1,950 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
Coming events: Events in English
Date | Date | Event | Days | Location |
12 nov 2024 | nov 12 | 17th Symposium on Pharmacokinetics and Drug Metabolism Mölndal | 2 | Mölndal |
18 mar 2025 | mar 18 | 2nd Nordic Conference on Computational Chemistry Göteborg | 2 | Göteborg |
Details
GDP Basic – management team
Period: e-kurs
Venue: Online
Town/City: Online
Participation fee
Price: 2600 SEK
Other info
GDP Basic - management team is supported by the Nordplus Horizontal Program.
All prices are excl VAT.
Kontakt
i Stockholm AB
Box 1136
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11
E-post: info@lakemedelsakademin.se
Org.nr: 556005-7043
Utbildningar
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