New Course from NIBRT Online Academy – Introduction to Quality Control Testing
This course provides a high-level general overview of the role of quality control testing and its importance in biopharmaceutical production.
Quality control testing is a GMP requirement for any type of pharmaceutical production. This course provides the context for this testing in a biopharmaceutical production process, describing the complexity of biopharmaceuticals, potential process sampling points for testing and some of the key regulatory documents concerning quality control testing. With this, this course also offers an overview of some of the key analytical methods used for this testing of biopharmaceuticals.
In addition to being a GMP requirement, quality control testing is essential part of the process, this is unfortunately demonstrated by some previous historical and recent devastating incidences, some of which are described in this course. Quality control testing has progressed since these events described, and continues to do so, as is also outlined in this course. Overall, this course provides an appreciation of the role of quality control testing and the direction it is moving.
Course Duration: approx. 60 mins.
Certificate of Completion: Yes
Course Access: 90 days
Enrol: Click here
Key Course Topics
- The necessity of quality control testing for biopharmaceuticals
- Overview of the general sampling points in a bioprocess
- Outline important regulatory documents
- Description of some of the common analytical methods used for testing
- Past, present and future quality control testing
- Describe the importance of quality control testing
- Define the framework of basic testing requirements of a biopharmaceutical drug
- Provide an overview of some routine analytical test method
Who Should Attend this Course?
Those who have limited or no experience in quality control testing for biopharmaceuticals , and who are looking to expand their knowledge in this area, and potentially move into a quality role. This course is designed for those who have an understanding of the biopharmaceutical manufacturing process and who have a basic awareness of protein structure and chemistry.