Clinical Importance of Objectionable Organisms

Why Should You Attend:

FDA expects manufacturers of non-sterile products to identify and prevent microorganisms that are objectionable. This responsibility lies with the manufacturer of the product. There is very little understanding in the industry on what organisms should be considered objectionable. At times the specified organisms outlined in the USP are not the only organisms that can harm the patient.

This webinar will help you identify objectionable microorganisms in your product beyond the specified organisms required to be tested per USP Microbial Limits Test. You will learn how to assess the risk to patient by understanding the clinical implications due to presence of objectionable microorganisms.

Areas Covered in the Webinar:

• FDA expectations regarding objectionable microorganisms
• Understanding USP <1111> and other guidelines related to objectionable microorganisms
• Bacteria and fungi that cause oral diseases and can be objectionable in oral and gingival products
• Bacteria and fungi that cause that cause naso-pharyngeal or lung infections and can be objectionable in nasal or inhalation products
• Bacteria and fungi that can be objectionable in aqueous and non-aqueous oral products
• Bacteria and fungi that can be objectionable in ointments and patches causing cutaneous and sub-cutaneous infections
• Bacteria and fungi that can cause ear and eye infections
• Microorganisms that can be objectionable in rectal and vaginal products
• Microorganisms that cause systemic infections
• Performing research on whether the microorganisms found in your product have a chance of causing harm to the patient
• FDA 483s related to lack of procedures for establishing objectionable microorganisms

Who will benefit:

This webinar will benefit companies in pharmaceuticals, biotechnology, medical devices and in-vitro diagnostics. The following personnel will benefit:

• Quality assurance
• Quality control microbiologists
• Microbiology laboratory personnel
• Manufacturing supervisors
• Clinical research professionals

Instructor Profile:

Ziva Abraham, President of Microrite, Inc., a San Jose, CA based consulting and training firm is a well known microbial contamination control expert with over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. Her hands-on experience in varied fields has provided her with the framework to understand the effects of microbial contamination and quality pitfalls from a patient safety perspective.

Ziva received her Master’s Degree in Microbiology and has conducted graduate work on developing Microbial Insecticides. She has established clinical laboratory systems in Israel, and is involved in expanding Your Horizons, a program through the Math and Science Network to educate young girls about careers in science. She uses her hands on experience in varied fields to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use or to diagnose disease in humans and/or animals. Microrite, Inc. which was founded in 1998 helps Pharmaceutical, Medical Device, Biotechnology, and In Vitro Diagnostic companies in the areas of microbiological quality control for sterile and non-sterile manufacturing, quality systems procedures, GAP assessment, audits, preparation for inspections, process development, facilities, utilities and equipment validation.

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