Improving Aseptic Processes and Monitoring to Reduce FDA 483s and Warning Letters
The FDA has increased warning letter distribution dramatically in recent years. Notably, there has been a significant increase in the number of warning letters referring to "data integrity" and "sterility assurance", in relation to environmental monitoring (EM).
Attend this online training to learn about the trends in types of warnings provided and what measures FDA inspectors have indicated that they want to see implemented in controlled environments. Our instructor will provide recommendations on avoiding 483s.
Gilberto Dalmaso, PhD
Senior Consultant and Pharma Customer Advisory Team Manager
Particle Measuring Systems
Gilberto Dalmaso has over 25 years’ experience in pharmaceutical microbiology and sterility assurance. In 2006, he was awarded an Honorary PhD in Pharmaceutical Microbiology from Università degli Studi di Milano in recognition of his innovative microbiological scientific studies and new technologies introduced to the pharmaceutical industry. Today he is a reporter to numerous symposia on the microbiology and Pharma in Europe and United States.