QA QC GXP for Pharmaceutical Production

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.

Participants must

• 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.

Course responsible
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.