Microbiological Quality Considerations in Non sterile Drug Manufacturing per FDA’s Guidance

About the Webinar
The focus of the webinar be :
Discussion on the key elements of the draft guidance
Assessing risk on non-sterile product-what you need to know
USP specified organisms vs the focus on objectionable microorganisms in the draft guidance
Significance of microbial identification in pathogen specific assessments
Special testing-what does it mean?
Key Take Aways from the Webinar
Key points to consider when establishing objectionability of microorganisms in various non-sterile products
How to investigate if a microorganism is objectionable in your product
Common identification errors that may lead to futile investigations
About Ziva Abraham
Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.