Description

Quality is the focus of everyone who works at Takeda BP. Therefore, the focus of the overall course is to provide a general understanding of the purpose of Pharmaceutical Quality Systems (PQS), how PQS functions at Takeda BP, and the participant’s role in PQS.

The Pharmaceutical Quality Systems Course is formatted differently than previous courses offered by the UMN/Takeda partnership. This course will be broken into 5 smaller modules. All participants must take TAK X401 Pharmaceutical Quality Systems: Overview Module first. See section information for meeting times, hours, and locations. The Overview module must be taken before taking any of the other modules in the series. After completing the Overview module, participants can take any combination of the remaining four modules and complete them. Participants do not have to take all the modules; they may choose the ones that interest them.

Objectives

At the end of this meeting participants will be able to …

1. Explain what a PQS is, what is in a PQS, and the importance of a well-functioning PQS
2. Explain the role of Knowledge Management and Risk Assessment in Quality Systems
3. Summarize the purpose and contents of the ICH Q10 PCS Pillars
4. Make connections between the ICH Q10 PQS Pillars and…
   • Takeda BP functions
   • Participant’s jobs
5. Describe how GMP systems map onto the ICH Q10 PQS pillars
   • LIMS, SAP, LEADs, Trackwise, RAM
6. Create a concept map illustrating Takeda BP functions and their role in Quality
   • To the map add in Management Hierarchy information
   • Discuss how ICH Q10 and 21 CFR 211 layer onto the mapped structure
7. Determine the impact of company culture on the PQS
8. Define the Quality Control Unit responsibilities as laid out in 21 CFR 211
   • Differentiate between QA and QC
9. How the ICH Q10 PQS pillars allow for the Disposition process.