QA QC GXP for Pharmaceutical Production
Obtain a broad overview of connections between all stages in the development process of a drug product with focus on the GXP areas.
This course is for you having an academic background with little or no knowledge of the different stages of the quality within development of a drug product. You will gain a broad overview of connections between all stages in the development process of a drug product with focus on the GXP areas, i.e. Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice and Good Distribution Practice.
The course is relevant for you aiming to gain a basic knowledge of the law / guidelines relevant for working in a GXP environment. Also, you will be able to see the link between the different areas of work, ex. activities related to testing in animals and in humans, pharmacovigilance, manufacturing and transportation of the drug product. You will experience that some of the laws / guidelines are quite similar between the different GXP areas, but varying in the focus and the way how they are interpreted.
This course is quite unique as most lecturers work in the pharmaceutical industry. Some lecturers work in the Danish Medicines Health Authority and are focusing on the latest trends within the inspection findings.
The topics include:
- International legislation GXP (meaning GLP, GCP, GMP and GDP): EU, FDA, PIC/S, ICH, OECD
- National legislation GXP: Medicinal Products Act, Executive orders on marketing authorisation, quality, labeling, manufacture, distribution and handling, Euphoriant Act
- Manufacturers authorization, authorization to handle euphoriant substances Company quality manual: Policies, guidelines, SOP's, work instruction
- QA/QC activities (GMP): Site master file, Audit of suppliers; audits within the group; self-inspection; deviation and change control systems; third party audits; authority inspections; handling of complaints and recall including pharmacovigilance matters; qualification/validation activities including document approval and authorization; SOP's approval and authorization; GXP training and documentation; harmonization of GXP activities within a company (laboratories/production); specifications; release of packaging materials; release of starting materials; release of API (Active Pharmaceutical Ingredients); release of finished products; certificates of analysis (COA); Certificate of Compliance (COC).
- QA/QC activities (GCP and GLP): Monitoring and audits
- QA/QC activities (GDP)
- Participation in industries association working groups discussing new legislation and harmonization of QA/QC activities, national and international.
By attending this course you will be able to:
- Understand the reason for a need to work with Quality Control (QC) and Quality Assurance (QA) within the different GXP areas
- Understand the complexity of working with different GXP laws / guidelines
- Understand how the GXP laws / guidelines are implemented within the company
- Learn the tools to continue to be in compliance with the GXP laws / guidelines
- Achieve an overview on how a drug is tested in animals, in humans, formulated as the final drug product and finally, challenges related to the transportation of the drug product in a controlled way (for the human study and to the final consumer)
Professionals in need of interdisciplinary overview
The course is intended for drug development professionals who are working within drug development and manufacturing related activities, and who need basic knowledge about legislation within drug development.
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience in drug development
- Be proficient in English
Find detailed information about the admission criteria.
Associate professor Natalja Genina, University of Copenhagen
Visiting experts from the pharmaceutical industry
Annette Byrholt Hansen, Danish Medicines Agency
Antony Pham, SPLY
Birthe Emilie Nielsen, Genmab
Bjørg Sandberg, H. Lundbeck A/S
Henriette Vindmar, pK Chemicals
Camilla Lundbye Castle, Pharmakon
Nusret Asanovski, GXP PharmAid
Mai Frederiksen Raun, Danish Medicines Agency
Tina Brouer, Pharmakon
The list may be subject to change.
This course is offered as an compulsory course in the Master of Industrial Drug Development programme.
Priority is given to students enrolled on Master of Industrial Drug Development. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
|Duration:||5 days on campus|
|Dates:||13-17 November 2023|
|Frequency:||Only available every second year|
|Place:||University of Copenhagen, Copenhagen, Denmark
|Course fee:||EU/EEA citizens: 10,750
Non-EU/EEA citizens: 12,543 DKK
The fee includes lunch/coffee.
|Level and credit:||Master's course; 2,5 ECTS|
|Examination date:||Announced in the winter 2023/2024 exam plan|
|Application deadline:||8 weeks prior to course start|
To be admitted, you must meet the admission criteria for Master of Industrial Drug Development
Course dates and application deadlines are announced via the programme newsletter.
Download course curriculum