Practical Solutions to Quality by Design Implementation

Quality by Design (QbD) is one of the most discussed and potentially most influential changes currently moving the pharmaceutical industry forward. With strong regulatory backing from both the FDA and the EMEA, the pharmaceutical and biotech industries are increasing their investments and efforts to integrate QbD into their development and production processes.

PTI’s 2-day interactive course, ‘Practical solutions to Quality-by-Design Implementation’ will demonstrate how to use QbD to ensure the highest quality of your products from an early development stage and will enable you to minimise risk and achieve regulatory compliance.

The main emphasis of this training programme will be on case studies and practical discussions in order to assess how your organisation can benefit from the successful implementation of QbD.

2 practical case studies plus a practical workshop:

Case Study in Pharma
• API Synthesis
• Designing a formulation for correct dissolution times
• Perfecting the coating process for release rate

Case Studies in Biopharma
• API from a natural source: problem solving
• Fermentation endpoint monitoring
• Following various bio-process in real-time

Practical Workshop: Forming and Justifying a PAT/QbD Team
• Who should be included and in what order?
• Who should be part-time and who full?
• Who deals with what part of the problem?
• How to set costs, benchmarks, goals