COURSE DESCRIPTION
OVERVIEW
The ICH documents Q8, Q9, and Q10 have been gaining attention recently with the new FDA quality metrics initiative and the announcement of the FDA’s pilot program for training inspectors to assess a quality culture . This means that expectations set in these guidances won’t be optional for much longer, and organizations must assess their own operations for “Quality by Design” (QbD) compliance.
This process is confusing for many companies because it’s a very different way of thinking and working. Although the three documents are written as standalone entities, in order to implement them, all three must be used together. And worse, there are other guidances (like FDA’s Process Validation Guidance) and requirements (like the cGMPs) that have to be factored into the process. Furthermore, if one part of the organization is ready and another isn’t, the process defined in Q8, Q9, and Q10 will run into difficulties.
Spending the time to incorporate the latest QbD expectations into your operations is critical.
LEARNING OBJECTIVES
In this interactive, 90-minute webinar you will learn:
- The differences between the old GMP mindset and the new quality systems mindset – and how they both affect our daily operations
- What each guidance covers, including scope and applicability to the various parts of the operations
- All of the parts required for an effective quality system (per these guidances and regulations), and how the systems should interact
- How to assess your own site processes and systems against the guidances
