Clinical Importance of Objectionable Organisms

This webinar on objectionable microorganisms will show how to identify and prevent objectionable microorganisms that are beyond the ones outlined in USP <1111>. Attendees will learn the clinical implications due to presence of objectionable microorganisms.

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