Course overview
For many years pharmaceutical companies have placed considerable effort in developing robust manufacturing processes to assure the highest quality products, minimize defects, eliminate rejects and conform to all Regulatory requirements. These processes are developed by scientists using past knowledge and 1 variable-at-a-time experiments and then subjected to process validation. Unfortunately, more often than not, even validated processes fail.
At the core of this problem is the fact that full process knowledge has not been acquired and all critical factors have not been identified. This implies that the manufacturing process can drift into a region not fully explored and produce an output that falls outside acceptable limits.
In this webinar participants will learn about
- Basic concepts of Quality by Design (QbD)
- Advantages of QbD over traditional 1 variable-at-a-time experimentation
- Statistical experimental design
- Critical factors
- Factor interactions
- Design space
- Interpretation of data derived from QbD
- A real life example of QbD applied to a pharmaceutical granulation process to fully understand the critical factors and the optimal operating range within the design space for those factors
Who should attend
The webinar is suitable for those who are seeking to get a basic understanding of the concept of Quality by Design and its application to pharmaceutical processing including personnel in Production, Quality Assurance, Quality Control, Validation and Development.
