Manufacturing, Quality Assurance, Distribution

GDP in Practice

This course gives you basic knowledge of GDP regulations and guidelines as well as an understanding of how to put these into practice and of how a GDP compliant drug distribution works for all parts of the supply chain. Perfect for those who need an overview of the most common GDP tasks at a pharmaceutical company, pharmacy or in a wholesale business. The course is given in Swedish (GDP i praktiken – grundkurs).

GDP Advanced Course

Gain in-depth knowledge and understanding of GDP regulations and guidelines through a deep dive into the quality system’s intent and a risk-based approach. The course provides you with practical tools as well as regulatory news and strengthens you in your quality role. The course day consists of lectures and group exercises mixed with discussion, exchange of experiences and networking with life science colleagues. The course is given in Swedish (GDP Fördjupning).

GDP Basic – e-course

An interactive e-learning that gives you GDP at a basic level. Developed in collaboration with leading experts in the field.
A good support tool for Responsible Persons, arranging the annual GDP training for the staff.
The training is available in Swedish and English with adaptation to different roles:
• QA and related roles
• Management Team
• Transport
• Manufacturing

The course is given in English and Swedish.

GMP Basic/GMP Refresher

Let us tailor your annual GMP training to your needs! Choose between or combine our two knowledge levels:

• GMP Basic – 3 hours course in fundamental GMP knowledge
• GMP Refresher – 3 hour annual refresher training within GMP with your choice of main focus

Courses are carried out on site at your premises or online in Swedish or English.

Practical QA release course

Do you work with QA release and want to broaden and strengthen your knowledge of QA’s role and responsibility in the practical release work? This course gives you knowledge of the governing regulations as well as practical interpretation and application for your chosen area of specialization, Manufacturing of commercial product, Manufacturing for clinical trials or Manufacturing for external parties. The course is given in Swedish (QA-release i praktiken).

GAMP 5 - Quality Assurance of Computerized Systems

Good Automated Manufacturing Practice (GAMP) is a guideline for quality assurance of computerized systems via a risk-based validation approach and according to a life cycle model. The gudieline is developed by experts in the pharmaceutical industry, to support interpreting and complying with regulations. Ultimately,  improve your compliance, quality, and efficiency in a cost-saving way! The course is given in Swedish (GAMP 5 – kvalitetssäkring av datoriserade system).

Quality assurance of computerized systems - in-depth course for Quality Managers

The Quality Assurance role is critical for the company’s computerized systems in GxP-regulated operations. This course gives you as a Quality Manager an in-depth understanding of the life cycle of a computerized system with a focus on interpretation of regulations and guidelines such as 21 CFR Part 11, EudraLex Volume 4 Annex 11 and Annex 15 as well as GAMP5. This course is given in Swedish (Kvalitetssäkring av datoriserade system – fördjupningskurs för dig inom QA).

Validation and Qualification

The course gives an insight to the basic tools and knowledge for effective validation and qualification work, through a risk-based approach for both process equipment and computerized systems in Life Science. The course is given in Swedish (Validering och Kvalificering).

Train the trainer - pedagogical tools for you who teach and train others

Are e you eager to sharpen your trainings? This is a 3-hour course for you who hold trainings internally at the office or for your customers, in your role as a Responsible Person, Project Manager or consultant within life science. The course is given in Swedish (Train the trainer – pedagogik och lärande för dig som utbildar).

Industrial Galenic Pharmacy, 7.5 credits

Do you have your sights set on becoming a Responsible Person? This course is offered by Uppsala University and provides basic knowledge in galenic pharmacy with an emphasis on the design, production and control of common ready-to-use pharmaceutical preparations. The course is held in Swedish (Industriell galenisk farmaci 7,5 hp).