This course is designed for quality and manufacturing professionals to develop a microbiological risk assessment based on specific pharmaceutical products or processes. Participants will learn to formulate a strategy to proactively look for areas of potential microbial contamination and minimize activities or processes that may cause risk.
Specific activities will include:
- Reviewing how microbiological quality may be impacted in steps throughout the manufacturing process
- Identifying risk assessment tools, including the Failure Modes and Affects Analysis (FMEA) approach
- Creating an example FMEA, incorporating process steps that may have microbial contamination risk
- Using the FMEA approach to evaluate process and behavior