This presentation will focus on the current trend of regulatory observations for sterile product manufacturing. The observations expanded upon will include, recurrent observations seen across the globe, repeat observations that are specific to certain functions and well as discussion on the reasons behind such observations. Gain an understanding of this trend of observations and why regulators consider them as GMP violations. Understand how the 483-observation rate provides a window into the FDA’s current thinking about compliance priorities. Comprehend the impact of these observations on other GMP functions, which observations are the most egregious and could result in some sort of a regulatory action. Common errors made which may lead to lack of confidence on the part of regulators. Gain a science based understanding on the causes of this recent trend of observations.
Ziva Abraham is the President and Founder of Microrite, Inc., a California based firm providing consulting and training services for medicinal product manufacturing. The team assembled by Ziva include; facility, airflow, particulate, sterilization, quality, validation and microbiology experts. Ziva’s team participates in industry standards and guidance organizations (IEST, AAMI, ISO, ASHRAE, USP and IP) as board or expert committee members.
Ziva has over 35 years of clinical and pharmaceutical microbiology as well as mycology experience. She has received her Master’s degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides utilizing entomogenous bacteria and fungi towards her Ph.D degree. Her career spans from founding and managing clinical laboratories for Maccabi Medical in Israel to working with pharmaceutical and medical devices companies.
As the principal microbiologist, and a part of her technical team, Ziva has helped large and small pharma, medical device, and drug device combination as well as diagnostic companies. The roles varied from development of proactive contamination control strategies through pragmatic risk assessment, troubleshooting contamination issues and helping with FDA 483/warning letter remediation activities.