QA QC GXP for Pharmaceutical Production

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.

WHAT YOU WILL LEARN

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)

COURSE CONTENT

This course is quite unique as all the teachers at this course are working in the pharmaceutical industry. Additionally, some teachers are from the Danish Medicines Health Authority 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.

PARTICIPANTS

Participants must meet the following criteria: 
- A relevant bachelor degree or equivalent 
- A minimum of 2 years of relevant job experience 
- Be proficient in English

COURSE DETAILS

Course dates

5 days - not scheduled. Expected to be offered again in autumn 2019.

Course fee

• DKK 10,750 for EU/EEA citizens
• DKK 12,543 for non-EU/EEA citizens 

Application deadline

To be announced

EXAMINATION

2 hours written examination under invigilation.

Examination design
The purpose of the examination is to test that the examinee has achieved the learning objectives. The exam is a combination of multiple-choice questions and case studies. The percentage of items on the test devoted to a particular topic will roughly correspond to the emphasis given the topic in teaching of the course, as implied in the general course objectives and abstracts of the topics.Credit

2,5 ECTS

Examination date

To be announced