Out of specifications (OOS) are an inevitable part of the pharmaceutical manufacturing environment, and no part of the process is immune from them – including endotoxin testing and microbial detection. However, not every investigational method is created equally. Using an ineffective method during an OOS investigation can lead to harsh consequences, such as wasted time and resources in chasing an incorrect root cause, potential regulatory action and scrutiny and more importantly, potentially delaying product release to patients who need them.
So, what tools are best for your investigations? Learn about the Six Sigma principles and how their use in OOS investigations can lead you to understand your processes better, allow for more efficient OOS investigations, enable you to drive to the true root cause, and ultimately lead to increased patient safety for your products. In this webinar we’ll discuss:
- Defining and implementing DMAIC (Define, Measure, Analyze, Improve, Control) for investigative purposes
- Effective tools for Corrective and Preventive Actions (CAPA)
- Methods that stress driving to root cause based on data and sound science
- Case studies that highlight real world uses for the proposed tools
Matthew Paquette, MBA
Lean Six Sigma and Quality Management, Operational Excellence Manager, Charles River