Paula Peacos

Points to Consider When Designing an Environmental Monitoring Trending Program
Wednesday, October 14, 2020
Environmental monitoring (EM) trending programs are an integral tool for use in making sound, scientifically justified cGMP decisions. Moreover, the usefulness of this tool is directly proportional to its quality, and that ... read more
Contamination Control Programs and the Microbiologist - The Changing Landscape
Monday, June 22, 2020
Holistic, risk-based microbiological contamination control programs are being implemented throughout the industry as a means of increasing patient safety and improving the levels of overall process control and product quality... read more
Microbiological Data Integrity: Points to Consider Regarding Second Analyst Verification
Wednesday, March 25, 2020
Data integrity is a topic of great importance in our industry. Robust data integrity is critical to ensuring patient safety by assuring that correct and appropriate decisions are made, and that all test results etc. ... read more
Using Contamination Rates For Environmental Monitoring Trending-It’s Not Just For Clean Rooms
Friday, February 16, 2018
Environmental monitoring is a tool utilized by the pharmaceutical industry to measure and monitor microbial bioburden levels in a manufacturing facility. read more
The Role of Microbiological Media in Maintaining Laboratory Data Integrity
Friday, September 30, 2016
In the pharmaceutical industry, the generation and collection of data is key to ensuring product quality and patient safety. As such, the integrity of this data is paramount. “Data integrity”, for the... read more
Bias: The Hidden Danger to Your Risk Assessment
Thursday, March 31, 2016
Quality risk management (QRM) is a systematic process for the assessment, control, communication and review of risks to the quality of a product or process over the entire product lifecycle. An effective QRM program can ... read more